Compounds > methylprednisolone acetate
Page last updated: 2024-12-05

methylprednisolone acetate

Description

Methylprednisolone Acetate: Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

methylprednisolone acetate : An acetate ester resulting from the formal condensation of the 21-hydroxy function of 6alpha-methylprednisolone compound with acetic acid. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5877
CHEMBL ID1364144
CHEBI ID6889
SCHEMBL ID13231
MeSH IDM0040839

Synonyms (112)

Synonym
methylprednisolone 21-acetate
medrol enpak
nsc48985
medrol acetate
mepred
pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6.alpha.,11.beta.)-
depo-medrone
component of neo-medrol
nsc-48985
depo-medrate
pregna-1,20-dione, 11.beta.,17,21-trihydroxy-6.alpha.-methyl-, 21-acetate
d-med
depomedrone
u 8210
urbason crystal suspension
(6alpha,11beta)-11,17-dihydroxy-6-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate
depo-medrol
depometicort
lemod depo
acetyl-methylprednisolone
einecs 200-171-3
nsc 48985
methylprednisolone-21-acetate
depo-medrin
pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-6alpha-methyl-, 21-acetate
solsolona [inj.]
ubrason [inj.]
pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6alpha,11beta)-
pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-, (6-alpha,11-beta)-
unidrol
6alpha-methylprednisolone acetate
depo-methylprednisolone acetate
methylprednisolone acetate
m-predrol
6alpha-methylprednisolone 21-acetate
53-36-1
C08179
11beta,17,21-trihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione 21-acetate
NCGC00159503-02
D00979
depo-medrol (tn)
methylprednisolone acetate (jan/usp)
MLS001304003
smr000718757
CHEBI:6889 ,
[2-[(6s,8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
HMS3259L07
tox21_111722
cas-53-36-1
dtxsid7023302 ,
dtxcid703302
HMS2233N14
AKOS015969745
ubrason
methyl prednisolone acetate
unii-43502p7f0p
methylprednisolone acetate [usp:jan]
solsolona
43502p7f0p ,
CHEMBL1364144
S5973
methylprednisolone acetate [orange book]
methylprednisolone acetate [usp monograph]
methylprednisolone acetate [ep monograph]
methylprednisolone acetate [green book]
methylprednisolone hydrogen succinate impurity c [ep impurity]
methylprednisolone impurity j [ep impurity]
methylprednisolone acetate [mart.]
methylprednisolone acetate component of neo-medrol acetate
neo-medrol acetate component methylprednisolone acetate
methylprednisolone acetate [vandf]
methylprednisolone acetate [usp-rs]
methylprednisolone acetate [usp impurity]
methylprednisolone acetate [jan]
methylprednisolone acetate [who-dd]
AB00375925-05
NC00628
SCHEMBL13231
bdbm233194
HY-13681
methylprednisolon-21-acetat
M2635
6alpha-methyl prednisolone 21-acetate
Q27107351
methylprednisolone ep impurity j
methylprednisolone acetate; 6?-methyl prednisolone 21-acetate; methylprednisolone hydrogen succinate ep impurity c; 11?,17-dihydroxy-6?-methyl-3,20-dioxopregna-1,4-dien21-yl acetate; 21-acetoxy-11?,17-dihydroxy-6?-methylpregna-1,4-diene-3,20-dione
PLBHSZGDDKCEHR-LFYFAGGJSA-N
methyl prednisolone 21-acetate
acetyl methylprednisolone
methylprednisolone 21 acetate
D87728
6 alpha -methylprednisolone 21-acetate
6?-methyl prednisolone 21-acetate
methylprednisolone acetate for peak identification
methylprednisolone acetate for system suitability
CS-0007549
methylprednisolone acetate (usp:jan)
hybrisil
medroloan suik
methylprednisolone acetate (mart.)
11beta,17alpha,21-trihydroxy-6alpha-methylpregna-1,4- diene-3,20-dione 21-acetate
methylprednisolone acetate inj.
methylprednisolone hydrogen succinate impurity c (ep impurity)
solsolona (inj.)
methylprednisolone acetate (usp impurity)
methylprednisolone acetate (ep monograph)
methylprednisolone impurity j (ep impurity)
methylprednisolone acetate (usp monograph)
methylprednisolone acetate (usp-rs)
medroloan ii suik
ubrason (inj.)
readysharp methylprednisolone 80

Research Excerpts

Effects

ExcerptReferenceRelevance
"Methylprednisolone acetate (MPA) has a long history of use in the treatment of sciatic pain and other neuropathic pain syndromes. "( The effects of glucocorticoids on neuropathic pain: a review with emphasis on intrathecal methylprednisolone acetate delivery.
Kalkman, CJ; Rijsdijk, M; van Wijck, AJ; Yaksh, TL, 2014)		2.07
"Methylprednisolone acetate (MPA) has a long history of use in the treatment of sciatic pain and other neuropathic pain syndromes. "( The effects of glucocorticoids on neuropathic pain: a review with emphasis on intrathecal methylprednisolone acetate delivery.
Kalkman, CJ; Rijsdijk, M; van Wijck, AJ; Yaksh, TL, 2014)		2.07

Actions

ExcerptReferenceRelevance
"Methylprednisolone acetate caused an increase in release of GAG into the medium at 48 and 72 hours after treatment."( Effects of sodium hyaluronate and methylprednisolone acetate on proteoglycan synthesis in equine articular cartilage explants.
Constable, PD; Doyle, AJ; Eurell, JA; Freeman, DE; Griffon, DJ; Stewart, AA, 2005)		1.33

Toxicity

Intrathecal methylprednisolone acetate (Depo-Medrol) therapy seems not fully safe due to reported adverse events.

ExcerptReferenceRelevance
" Thus, toxic effects can be caused by preservatives or inadequate osmolarity of the vehicles alone."( Experimental and clinical observations of the intraocular toxicity of commercial corticosteroid preparations.
Arena, JE; Chandler, D; Hida, T; Machemer, R, 1986)		0.27
" The LD50 values of THS-201 both in mice and rats were estimated more than 5000 mg/kg at each route, and these are for above larger than those of TA or MPA."( [Study on toxicity of halopredone acetate. (I) Acute toxicity study in mice and rats].
Ichinohe, M; Kaga, M; Okazaki, S; Shinpo, K; Sudo, J; Takeuchi, M; Tanabe, T; Tsuga, T, 1985)		0.27
"Systemic toxic effects may develop as a result of topical and local use of ophthalmic corticosteroid preparations in susceptible patients."( Systemic toxicity of topical and periocular corticosteroid therapy in an 11-year-old male with posterior uveitis.
Cheng, L; Freeman, WR; Levi, L; Ozerdem, U; Scher, C; Song, MK, 2000)		0.31
" All adverse effects were self-limiting."( Side effects of postoperative administration of methylprednisolone and gentamicin into the posterior sub-Tenon's space.
Mercieca, F; Mercieca, K, 2007)		0.34
"Celiac plexus neurolysis and block are considered safe but provide limited pain relief."( Initial evaluation of the efficacy and safety of endoscopic ultrasound-guided direct Ganglia neurolysis and block.
Chari, ST; Clain, JE; de la Mora, JG; Gleeson, FC; Levy, MJ; Pearson, RK; Pelaez, MC; Petersen, BT; Rajan, E; Topazian, MD; Vege, SS; Wang, KK; Wiersema, MJ, 2008)		0.35
" The WOMAC scale was applied at 4 weeks and adverse events were recorded."( Safety and efficacy of methylprednisolone infiltration in anserine syndrome treatment.
Esquivel-Valerio, JA; Galarza-Delgado, DÁ; Garza-Elizondo, MA; Negrete-López, R; Vega-Morales, D, )		0.13
" The incidence of adverse events did not show any differences either."( Safety and efficacy of methylprednisolone infiltration in anserine syndrome treatment.
Esquivel-Valerio, JA; Galarza-Delgado, DÁ; Garza-Elizondo, MA; Negrete-López, R; Vega-Morales, D, )		0.13
" Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018)		0.48
" There were no procedure-related serious adverse events."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018)		0.48
" A description of clinical and histological effects of polyethylene glycol and miripirium after Depo-Medrol injection, and the adverse reactions of particulate methylprednisolone acetate was conducted."( Safety of intrathecal route: focus to methylprednisolone acetate (Depo-Medrol) use.
Cisternino, S; Fontan, JE; Kabiche, S; Nguyen, D; Schlatter, J; Zamy, M, 2019)		0.98
"Intrathecal methylprednisolone acetate (Depo-Medrol) therapy seems not fully safe due to reported adverse events."( Safety of intrathecal route: focus to methylprednisolone acetate (Depo-Medrol) use.
Cisternino, S; Fontan, JE; Kabiche, S; Nguyen, D; Schlatter, J; Zamy, M, 2019)		1.16

Pharmacokinetics

ExcerptReferenceRelevance
"The absolute bioavailability and pharmacokinetic parameters of two methylprednisolone formulations (methylprednisolone sodium succinate and methylprednisolone acetate) were determined in five dogs."( Pharmacokinetics of methylprednisolone, methylprednisolone sodium succinate, and methylprednisolone acetate in dogs.
Alvinerie, M; Fayolle, PM; Koritz, GD; Toutain, PL, 1986)		0.7

Compound-Compound Interactions

ExcerptReferenceRelevance
" In the present study, the authors conducted a randomized controlled trial to compare the success of treatment between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization."( Randomized controlled trial between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization in the treatment of dorsal carpal ganglion.
Limpaphayom, N; Wilairatana, V, 2004)		0.75

Bioavailability

ExcerptReferenceRelevance
" This method was successfully implemented for the analysis of specimens generated from a single-dose bioavailability and safety study for a new formulation of Depo-Medrol sterile aqueous suspension."( Validation of the simultaneous determination of methylprednisolone and methylprednisolone acetate in human plasma by high-performance liquid chromatography.
Addison, TE; Brisson, J; Hopkins, NK; Wagner, CM, 1992)		0.52
"The absolute bioavailability and pharmacokinetic parameters of two methylprednisolone formulations (methylprednisolone sodium succinate and methylprednisolone acetate) were determined in five dogs."( Pharmacokinetics of methylprednisolone, methylprednisolone sodium succinate, and methylprednisolone acetate in dogs.
Alvinerie, M; Fayolle, PM; Koritz, GD; Toutain, PL, 1986)		0.7
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)		0.51
" The drug has low and fluctuating oral bioavailability owing to its extensive hepatic first-pass metabolism and reduced water solubility."( Investigating the potential of utilizing glycerosomes as a novel vesicular platform for enhancing intranasal delivery of lacidipine.
Abdel Halim, SA; Badr-Eldin, SM; Naguib, MJ; Salah, S, 2020)		0.56

Dosage Studied

The aim of this study was to compare the effectiveness of triamcinolone hexacetonide (THA) and methylprednisolone acetate (MPA) given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion.

ExcerptRelevanceReference
" Serum methylprednisolone levels rose rapidly, giving a dose-response curve similar to that after an intramuscular injection in humans."( The systemic and local effects of an intramedullary injection of methylprednisolone acetate in growing rabbits.
Aronson, DD; Colville, MR; Crissman, JD; Prcevski, P, )		0.37
" The optimal routes of administration, dosage, dosage interval, and other factors are unknown."( Intermediate-dose intramuscular methylprednisolone acetate in the treatment of rheumatic disease.
Kovarsky, J, 1983)		0.55
" The results reported in this paper have shown that glucocorticoid dosing produces numerous effects on motor neuron excitability and impulse generation and conduction."( Glucocorticoid effects on the electrical properties of spinal motor neurons.
Hall, ED, 1982)		0.26
" 2) Eight week treatment with the selected dosing regimen (n = 6) of the steroid and histomorphometry including strut analysis measured the development of a characteristic osteopenia which can be described briefly as "uncut but thinning" of trabecular bone structure, and which was prevented by salmon calcitonin (0."( Glucocorticoid-induced osteopenia in rats: histomorphometrical and microarchitectural characterization and calcitonin effect.
Hoshino, T; Koida, M; Nakamuta, H; Nitta, T, 1996)		0.29
" The highest dosage of MPA (10 mg/ml) reduced GAG synthesis less than lower dosages of MPA and all dosages of TA."( Effects of dosage titration of methylprednisolone acetate and triamcinolone acetonide on interleukin-1-conditioned equine articular cartilage explants in vitro.
Baxter, GM; Dechant, JE; Frisbie, DD; McIlwraith, CW; Trotter, GW, 2003)		0.6
"The aim of this study was to compare the effectiveness of triamcinolone hexacetonide (THA) and methylprednisolone acetate (MPA), given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion, in a double-blind randomized comparative trial."( Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate.
Bhanji, A; Ioannou, Y; Mootoo, R; Pyne, D, 2004)		0.76
" The use of systemic corticosteroids in the treatment of TEN is controversial because of a lack of randomized, controlled, prospective studies, and because the effects of steroid therapy vary depending on the dosage and time of its administration during the course of TEN."( Skin biopsies to assess response to systemic corticosteroid therapy in early-stage TEN: case report and review of the literature.
Céspedes, YP; Nigra, TP; O'Donoghue, JM; Rockley, PF, 2009)		0.35
" The dosage of immunosuppressive systemic therapy was reduced or able to be stopped in three patients (50%)."( Periocular corticosteroid injection in the management of uveitis in children.
Grigg, JR; Habot-Wilner, Z; Kabasele, PM; Lightman, S; McCluskey, P; Roufas, A; Sallam, A, 2010)		0.36
"Pharmacokinetics of MP may differ among IA MPA dosing protocols, and MP may be detected in plasma and urine for a longer time than previously reported."( Pharmacokinetics of methylprednisolone acetate after intra-articular administration and subsequent suppression of endogenous hydrocortisone secretion in exercising horses.
Bertone, AL; Hothem, EA; Menéndez, MI; Phelps, MA, 2012)		0.7
" Transdermal drug delivery system is the main route with discrete, self-contained dosage forms when placed on the skin, transporting the medicament through the skin into the systemic circulation in a wellcontrolled manner."( Design and Evaluation of Transdermal Patches of Timolol Maleate.
Jamakandi, VG; Panchayya Hiremath, SS; Reddy, JJ, 2018)		0.48
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (8)

ClassDescription
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
acetate esterAny carboxylic ester where the carboxylic acid component is acetic acid.
steroid ester
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (18)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency22.38720.003245.467312,589.2998AID2517
USP1 protein, partialHomo sapiens (human)Potency0.28180.031637.5844354.8130AID743255
TDP1 proteinHomo sapiens (human)Potency0.25930.000811.382244.6684AID686979
AR proteinHomo sapiens (human)Potency0.61670.000221.22318,912.5098AID743035; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.06710.000214.376460.0339AID720691; AID720692; AID720719
estrogen nuclear receptor alphaHomo sapiens (human)Potency4.46060.000229.305416,493.5996AID743069; AID743075; AID743078; AID743079; AID743091
IDH1Homo sapiens (human)Potency11.58210.005210.865235.4813AID686970
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.04730.001723.839378.1014AID743083
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency7.94330.10009.191631.6228AID1346983
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.05170.00419.984825.9290AID504444; AID720524
importin subunit beta-1 isoform 1Homo sapiens (human)Potency32.64275.804836.130665.1308AID540253
snurportin-1Homo sapiens (human)Potency32.64275.804836.130665.1308AID540253
GTP-binding nuclear protein Ran isoform 1Homo sapiens (human)Potency32.64275.804816.996225.9290AID540253
urokinase-type plasminogen activator precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
plasminogen precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
urokinase plasminogen activator surface receptor precursorMus musculus (house mouse)Potency10.00000.15855.287912.5893AID540303
gemininHomo sapiens (human)Potency0.44860.004611.374133.4983AID624296; AID624297
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Glucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)Ki540.50001.19105.12919.9410AID1802951
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (23)

Processvia Protein(s)Taxonomy
pentose-phosphate shuntGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
lipid metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
cholesterol biosynthetic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
NADP metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
NADPH regenerationGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
glutathione metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
pentose-phosphate shunt, oxidative branchGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
response to iron(III) ionGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
negative regulation of protein glutathionylationGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
response to organic cyclic compoundGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
pentose biosynthetic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
substantia nigra developmentGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
response to foodGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
cellular response to oxidative stressGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
erythrocyte maturationGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
regulation of neuron apoptotic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
response to ethanolGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
ribose phosphate biosynthetic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
glucose 6-phosphate metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
negative regulation of cell growth involved in cardiac muscle cell developmentGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
positive regulation of calcium ion transmembrane transport via high voltage-gated calcium channelGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
negative regulation of reactive oxygen species metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
glucose metabolic processGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (6)

Processvia Protein(s)Taxonomy
glucose-6-phosphate dehydrogenase activityGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
protein bindingGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
glucose bindingGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
identical protein bindingGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
protein homodimerization activityGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
NADP bindingGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (7)

Processvia Protein(s)Taxonomy
cytoplasmGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
cytosolGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
cytoplasmic side of plasma membraneGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
membraneGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
centriolar satelliteGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
intracellular membrane-bounded organelleGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
extracellular exosomeGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
cytosolGlucose-6-phosphate 1-dehydrogenaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (21)

Assay IDTitleYearJournalArticle
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1802951In Vitro Inhibition Assay from Article 10.3109/14756360903489581: \\Effects of some drugs on human erythrocyte glucose 6-phosphate dehydrogenase: an in vitro study.\\2010Journal of enzyme inhibition and medicinal chemistry, Dec, Volume: 25, Issue:6
Effects of some drugs on human erythrocyte glucose 6-phosphate dehydrogenase: an in vitro study.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (704)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990193 (27.41)18.7374
1990's126 (17.90)18.2507
2000's162 (23.01)29.6817
2010's198 (28.13)24.3611
2020's25 (3.55)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 59.69

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index59.69 (24.57)
Research Supply Index6.84 (2.92)
Research Growth Index4.55 (4.65)
Search Engine Demand Index101.99 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (59.69)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials157 (20.13%)5.53%
Reviews26 (3.33%)6.00%
Case Studies132 (16.92%)4.05%
Observational1 (0.13%)0.25%
Other464 (59.49%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (714)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Comparative Study of Strategies for Management of Duchenne Myopathy in Assiut University Children Hospital [NCT03633565]Phase 445 participants (Anticipated)Interventional2018-09-30Not yet recruiting
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial [NCT04791202]Phase 3130 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise [NCT01140932]10 participants (Actual)Interventional2010-02-28Completed
EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial) [NCT02459392]300 participants (Actual)Interventional2021-12-31Completed
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification [NCT01193504]Phase 4100 participants (Anticipated)Interventional2010-09-30Recruiting
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis [NCT01205984]Phase 448 participants (Actual)Interventional2007-07-31Completed
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids [NCT03974867]72 participants (Anticipated)Interventional2019-07-31Not yet recruiting
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars [NCT05752305]Phase 2/Phase 384 participants (Actual)Interventional2022-01-15Completed
A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) [NCT04127578]Phase 1/Phase 220 participants (Anticipated)Interventional2020-01-03Recruiting
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. [NCT01134432]Phase 365 participants (Actual)Interventional2005-03-31Completed
[NCT01137084]300 participants (Anticipated)Interventional2005-01-31Completed
Steroid Treatment as Anti-inflammatory and Neuroprotective Agent Following Out-of-Hospital Cardiac Arrest. A Randomized Trial [NCT04624776]Phase 2158 participants (Actual)Interventional2020-10-10Completed
An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD) [NCT01140984]2 participants (Actual)Interventional2010-09-30Terminated(stopped due to technical issues)
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis [NCT05842681]30 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial [NCT03876444]Phase 2/Phase 3128 participants (Anticipated)Interventional2019-04-01Recruiting
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study [NCT05280626]Phase 2100 participants (Anticipated)Interventional2022-03-25Not yet recruiting
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL [NCT03745664]Phase 3122 participants (Anticipated)Interventional2021-01-10Recruiting
A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge M [NCT03320434]Phase 2120 participants (Actual)Interventional2017-10-13Completed
Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT03701698]Phase 230 participants (Anticipated)Interventional2018-11-01Not yet recruiting
Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic [NCT03652480]20 participants (Actual)Observational2013-03-31Completed
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study [NCT01106547]Phase 455 participants (Anticipated)Interventional2009-08-31Completed
Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. [NCT03942861]50 participants (Anticipated)Observational2019-02-21Recruiting
A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis [NCT01132677]78 participants (Anticipated)Interventional2010-05-31Enrolling by invitation
Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients [NCT01874860]Phase 224 participants (Actual)Interventional2013-08-31Completed
Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis [NCT03564106]Phase 2/Phase 340 participants (Actual)Interventional2019-03-01Completed
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease [NCT03584516]Phase 2/Phase 3155 participants (Actual)Interventional2019-01-17Active, not recruiting
High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma [NCT01177371]Phase 213 participants (Actual)Interventional1988-03-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty [NCT02445898]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release. [NCT02448316]Phase 430 participants (Actual)Interventional2015-04-01Completed
Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery [NCT03190642]Phase 4180 participants (Actual)Interventional2018-01-01Completed
Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department [NCT03698630]Phase 4250 participants (Actual)Interventional2011-07-06Completed
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study [NCT02403856]Phase 4136 participants (Actual)Interventional2015-04-04Completed
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease [NCT02392780]Phase 210 participants (Anticipated)Interventional2015-04-30Not yet recruiting
DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses [NCT04479748]Phase 413 participants (Actual)Interventional2020-10-01Completed
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620]Phase 2453 participants (Anticipated)Interventional2021-10-19Recruiting
Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation? [NCT01380912]160 participants (Anticipated)Observational2010-08-31Recruiting
Evaluating Clinical and Immunological Effects of Rituximab With Cyclophosphamide Compared to Rituximab Alone in AAV Patients [NCT03942887]Phase 3100 participants (Anticipated)Interventional2019-05-03Recruiting
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection [NCT02331862]Phase 3160 participants (Anticipated)Interventional2015-01-31Not yet recruiting
A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome [NCT05137496]Phase 340 participants (Anticipated)Interventional2022-06-01Not yet recruiting
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection [NCT04780581]Phase 4127 participants (Actual)Interventional2021-02-01Terminated(stopped due to Impossibility of reaching the sample size established by protocol)
An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid) [NCT02962284]Phase 220 participants (Actual)Interventional2016-11-30Completed
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial [NCT02847494]Phase 4220 participants (Actual)Interventional2016-09-01Completed
Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis [NCT03794505]Phase 340 participants (Actual)Interventional2018-04-01Completed
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis [NCT01305837]Phase 230 participants (Actual)Interventional2011-04-30Completed
Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis [NCT05280873]Phase 148 participants (Anticipated)Interventional2021-10-10Recruiting
Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study [NCT03694821]Phase 418 participants (Actual)Interventional2018-07-05Terminated(stopped due to Low enrollment)
The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study [NCT02098330]Phase 340 participants (Actual)Interventional2014-03-31Completed
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study [NCT06119490]Early Phase 130 participants (Anticipated)Interventional2023-07-05Recruiting
Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine [NCT03704584]Phase 462 participants (Actual)Interventional2019-05-14Terminated(stopped due to Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.)
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma [NCT01332617]Phase 20 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to Investigators no longer interested in activating study)
Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial [NCT01354483]Phase 1/Phase 220 participants (Actual)Interventional2011-09-30Completed
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. [NCT01941589]Phase 4149 participants (Actual)Interventional2013-09-30Completed
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury [NCT04988425]Phase 1/Phase 290 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT00109928]Phase 234 participants (Actual)Interventional2005-09-30Completed
A Phase II, Open-labeled, Ophthalmological External Investigator-blinded, Single-center, Randomized, Superiority, Non Profit, Pilot Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO) in Hypercholesterolemic Patients With Mo [NCT03110848]Phase 288 participants (Actual)Interventional2020-06-01Completed
Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma [NCT05707572]62 participants (Actual)Interventional2014-09-30Completed
Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 [NCT02048358]Phase 147 participants (Actual)Interventional2013-11-30Terminated
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes. [NCT02176304]Phase 460 participants (Actual)Interventional2014-06-30Completed
[NCT01281748]Phase 483 participants (Actual)Interventional2005-07-31Terminated(stopped due to Low rate of enrollment)
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata [NCT01167946]Phase 442 participants (Actual)Interventional2003-01-31Completed
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01189864]3,493 participants (Actual)Observational2010-02-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study [NCT01560052]503 participants (Actual)Interventional2012-05-05Completed
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) [NCT00418145]Phase 316 participants (Actual)Interventional2003-09-30Terminated(stopped due to low enrollment - data was not analyzed for this study)
A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Rela [NCT01039103]Phase 215 participants (Actual)Interventional2009-12-31Terminated
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study [NCT03760354]Phase 230 participants (Anticipated)Interventional2019-02-15Not yet recruiting
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method [NCT05930236]40 participants (Anticipated)Interventional2023-04-21Recruiting
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) [NCT02953678]Phase 271 participants (Actual)Interventional2016-12-30Completed
Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) [NCT03387046]Phase 27 participants (Actual)Interventional2018-03-26Terminated(stopped due to Study was terminated early due to slow recruitment rate.)
A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adu [NCT04610476]Phase 3270 participants (Anticipated)Interventional2020-10-19Recruiting
A Multicentre Double-blind Randomised Controlled Trial to Assess the Clinical- and Cost-effectiveness of Facet-joint Injections in Selected Patients With Non-specific Low Back Pain: a Feasibility Study [NCT03339362]Phase 49 participants (Actual)Interventional2015-07-31Completed
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion [NCT03327272]Phase 30 participants (Actual)Interventional2018-05-22Withdrawn(stopped due to Did not enroll, PI decided not to proceed.)
Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA [NCT02205489]Phase 458 participants (Actual)Interventional2014-10-31Completed
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) [NCT05436652]Phase 248 participants (Anticipated)Interventional2022-07-22Recruiting
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye [NCT04184999]Phase 440 participants (Actual)Interventional2019-08-10Completed
A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections [NCT01397552]8 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low enrollment, too many subjects getting second injection)
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948]Phase 297 participants (Actual)Interventional2009-09-01Active, not recruiting
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE [NCT03355482]Phase 240 participants (Anticipated)Interventional2017-04-10Suspended(stopped due to recruitment, funding)
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion [NCT03308084]Phase 3105 participants (Actual)Interventional2015-11-13Completed
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract [NCT05191706]Phase 460 participants (Anticipated)Interventional2022-01-04Recruiting
A Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS) [NCT02462252]Phase 211 participants (Actual)Interventional2015-10-31Completed
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle [NCT03529929]Phase 30 participants (Actual)Interventional2019-06-01Withdrawn(stopped due to withdrawn)
The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial [NCT02439866]Phase 390 participants (Anticipated)Interventional2014-02-28Recruiting
A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385]Phase 1/Phase 244 participants (Actual)Interventional2014-10-31Completed
Targeting Steroid Resistance During Acute Exacerbations of Chronic Obstructive Pulmonary Disease With Respiratory Failure - The AECOPD Resistance Study [NCT03680495]46 participants (Anticipated)Observational [Patient Registry]2017-07-21Recruiting
Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears [NCT05317624]Early Phase 160 participants (Actual)Interventional2021-08-10Completed
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study [NCT03674099]Phase 2200 participants (Anticipated)Interventional2018-10-01Recruiting
Calcific Tendinitis: Comparing Minimally Invasive Modalities [NCT02367560]60 participants (Anticipated)Interventional2015-07-31Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty [NCT02332616]Phase 370 participants (Actual)Interventional2015-01-31Completed
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study. [NCT02039804]Phase 330 participants (Anticipated)Interventional2014-03-31Not yet recruiting
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose LY3884961 in Infants With Type 2 Gaucher Disease [NCT04411654]Phase 1/Phase 215 participants (Anticipated)Interventional2021-06-29Recruiting
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study [NCT05947669]Phase 3195 participants (Anticipated)Interventional2023-08-22Recruiting
[NCT02591953]22 participants (Actual)Interventional2015-11-30Terminated(stopped due to Unable to meet enrollment and follow up criteria)
Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction [NCT05462730]Phase 2530 participants (Actual)Interventional2022-11-14Active, not recruiting
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial [NCT05444699]Phase 4210 participants (Anticipated)Interventional2022-10-11Recruiting
Transforaminal Epidural Injection in Acute Sciatica [NCT03924791]142 participants (Anticipated)Interventional2019-06-01Recruiting
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial [NCT01496976]Phase 245 participants (Actual)Interventional2012-03-30Active, not recruiting
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis [NCT00676832]Phase 2190 participants (Actual)Interventional2008-05-31Completed
Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder [NCT05037994]40 participants (Actual)Interventional2021-04-01Completed
A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in [NCT05724446]Phase 360 participants (Anticipated)Interventional2022-12-12Recruiting
Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis [NCT05137522]20 participants (Anticipated)Interventional2021-07-01Recruiting
Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial [NCT02140632]Phase 450 participants (Actual)Interventional2013-12-31Completed
[NCT02253966]Phase 248 participants (Actual)Interventional2014-10-31Completed
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT02160132]Phase 2180 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand [NCT05003596]Phase 2/Phase 360 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease [NCT04987450]40 participants (Anticipated)Observational2018-10-01Recruiting
A Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome [NCT02167698]52 participants (Actual)Interventional2014-02-28Terminated(stopped due to Increased mortality in the intervention arm at 50% enrolment)
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry [NCT04151082]Phase 1/Phase 215 participants (Actual)Interventional2019-10-31Active, not recruiting
Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study [NCT05717374]80 participants (Anticipated)Interventional2023-02-13Recruiting
The Efficacy and Safety of 36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-Induced Liver Injury [NCT03266146]Phase 1/Phase 290 participants (Actual)Interventional2017-09-02Completed
The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin [NCT05951504]Phase 2/Phase 329 participants (Actual)Interventional2022-06-22Completed
Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 [NCT04979650]Phase 2104 participants (Anticipated)Interventional2021-05-22Enrolling by invitation
The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU [NCT04909918]Phase 360 participants (Actual)Interventional2021-05-28Completed
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study [NCT04900948]Phase 4108 participants (Actual)Interventional2017-12-10Completed
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study [NCT04863742]Phase 430 participants (Anticipated)Interventional2021-04-26Recruiting
Single-blind, Investigator-initiated, Randomized, Controlled Trial to Assess the Safety and Efficacy of Intravenous Corticosteroid Therapy to Treat Patients With Acute Myocarditis With Mildly Reduced Left Ventricular Ejection Fraction [NCT05974462]Phase 3174 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Evaluation of the Feasibility of Depomedrol Added to Bupivacaine in Ultrasound-guided Genicular Nerve Block in the Combination With Adductor Canal Block for Postoperative Analgesia and Rehabilitation After Reconstructive Knee Surgery. [NCT05893771]48 participants (Actual)Interventional2023-06-07Completed
Mechanisms of Neurodynamic Treatments (MONET) [NCT05859412]108 participants (Anticipated)Interventional2023-04-13Recruiting
Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial [NCT05859269]Phase 4200 participants (Anticipated)Interventional2023-10-16Recruiting
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo [NCT02521298]60 participants (Actual)Interventional2015-10-31Completed
Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain: Comparative Study Versus Corticosteroid Injection [NCT04467450]Early Phase 136 participants (Anticipated)Interventional2020-06-01Recruiting
Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome [NCT03371498]Phase 3356 participants (Anticipated)Interventional2018-12-27Recruiting
High-dose Intravenous Methylprednisolone Therapy in Patients With Graves' Orbitopathy is Associated With the Increased Activity of Factor VIII [NCT03535090]26 participants (Actual)Observational2011-01-01Completed
Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial [NCT05113901]Phase 44 participants (Actual)Interventional2022-03-03Terminated(stopped due to Extremely low participation, decided to focus on similar study instead)
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial [NCT03875690]Phase 31,200 participants (Anticipated)Interventional2019-07-02Recruiting
Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS [NCT04467892]Phase 2240 participants (Actual)Interventional2018-01-02Completed
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147]Phase 3475 participants (Anticipated)Interventional2017-08-08Recruiting
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura [NCT03647852]150 participants (Anticipated)Interventional2019-09-01Recruiting
A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma [NCT02304094]64 participants (Anticipated)Interventional2015-10-31Recruiting
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT03139604]Phase 3439 participants (Actual)Interventional2017-07-19Completed
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study [NCT03491098]Early Phase 160 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis: a Randomized Controlled Trial [NCT05626387]Phase 4144 participants (Anticipated)Interventional2022-11-23Recruiting
A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer [NCT03661567]Phase 252 participants (Actual)Interventional2018-08-09Terminated(stopped due to slow enrollment)
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy. [NCT03948191]Phase 450 participants (Actual)Interventional2017-10-16Completed
A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children [NCT01217099]47 participants (Actual)Interventional2007-05-31Terminated(stopped due to terminated)
Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery [NCT01218737]Phase 3101 participants (Actual)Interventional2009-01-31Completed
Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment [NCT01205477]Phase 258 participants (Actual)Interventional2009-09-30Completed
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation [NCT02495662]Phase 230 participants (Actual)Interventional2015-11-30Terminated(stopped due to Slow inclusion)
Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis [NCT05863936]Phase 315 participants (Anticipated)Interventional2023-04-01Recruiting
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus [NCT04874610]15 participants (Actual)Observational2021-08-16Completed
A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL [NCT01465334]Phase 230 participants (Actual)Interventional2011-12-31Terminated(stopped due to Terminated early due to change in practice.)
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial [NCT02422368]Phase 2/Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to Do not access to the drug)
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267]Phase 249 participants (Anticipated)Interventional2020-08-21Recruiting
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate [NCT01000610]Phase 418 participants (Actual)Interventional2008-03-17Completed
A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab [NCT00379431]Phase 29 participants (Actual)Interventional2006-11-27Completed
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients [NCT00627731]Phase 450 participants (Actual)Interventional2007-06-30Completed
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993]Phase 3210 participants (Actual)Interventional1998-03-16Completed
Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis [NCT02571517]Phase 494 participants (Actual)Interventional2011-11-30Completed
Viral Inception of Asthma: Prospective Study From Infancy to School-age. [NCT00731575]200 participants (Anticipated)Interventional2007-06-30Active, not recruiting
Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery [NCT02666703]Phase 360 participants (Actual)Interventional2016-02-01Completed
Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis [NCT02645565]Phase 475 participants (Actual)Interventional2015-12-31Completed
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial [NCT05971004]62 participants (Actual)Interventional2022-04-13Completed
Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment? [NCT00764413]57 participants (Actual)Interventional2009-04-30Terminated(stopped due to Low inclusion frequency and not enough human resources for completing study)
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial [NCT03913702]Phase 21 participants (Actual)Interventional2019-09-09Terminated(stopped due to Inadequate patient enrollment)
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy [NCT00595335]Phase 2/Phase 325 participants (Actual)Interventional2008-04-30Completed
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis [NCT03479502]Phase 41 participants (Actual)Interventional2018-01-05Terminated(stopped due to Lack of personnel to help with recruiting)
A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis [NCT01838174]Phase 437 participants (Actual)Interventional2013-05-31Terminated(stopped due to Sponsor requested)
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate. [NCT00805519]Phase 4230 participants (Actual)Interventional2009-02-28Completed
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate [NCT00634933]Phase 2222 participants (Actual)Interventional2008-03-31Terminated(stopped due to The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a [NCT02224105]Phase 156 participants (Actual)Interventional2010-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial) [NCT05570409]Phase 2/Phase 3130 participants (Anticipated)Interventional2023-03-28Recruiting
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches [NCT04685772]25 participants (Anticipated)Observational [Patient Registry]2021-04-01Recruiting
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease [NCT04509219]Phase 110 participants (Anticipated)Interventional2020-04-15Recruiting
The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial [NCT03898154]Phase 4200 participants (Anticipated)Interventional2019-07-10Recruiting
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19 [NCT04499313]Phase 360 participants (Anticipated)Interventional2020-08-02Recruiting
A Feasibility Study to Undertake a Definitive Randomised Multi-centre, Double-blind, Double-dummy Controlled Study of a Novel Agent Anakinra vs. Depo-Medrone for Acute Gout Attacks in Patients With Moderate Chronic Kidney Disease [NCT02578394]Phase 2/Phase 321 participants (Actual)Interventional2016-04-30Completed
Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy [NCT04493463]Phase 4132 participants (Actual)Interventional2020-07-31Completed
Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes [NCT02036125]50 participants (Anticipated)Interventional2013-10-31Recruiting
Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss [NCT02049073]Phase 1/Phase 20 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to new data makes this trial unethical)
Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis [NCT05302232]80 participants (Anticipated)Interventional2022-04-18Not yet recruiting
Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study [NCT05047874]200 participants (Anticipated)Observational2021-09-20Recruiting
An Open-Label, Parallel Group, Controlled Study in Healthy Subjects to Characterize Biological Responses to Immunological Challenges and to Measure the Effect of Marketed Anti-Inflammatory Agents on Those Responses [NCT02252809]Early Phase 151 participants (Actual)Interventional2008-11-30Completed
Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis [NCT04157036]Phase 33 participants (Actual)Interventional2020-02-01Terminated(stopped due to COVID halted recruitment for 2 years. A majority of patients eligible for the study had already taken preoperative analgesics, which disqualified them for the study.)
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome [NCT04933292]Phase 478 participants (Anticipated)Interventional2021-06-16Recruiting
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study [NCT04485429]Phase 30 participants (Actual)Interventional2020-07-20Withdrawn(stopped due to It was not possible to perform the study due to the availability and logistics of porcine heparin)
Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) [NCT05986422]Phase 2418 participants (Anticipated)Interventional2023-10-01Recruiting
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT04833374]Phase 3200 participants (Anticipated)Interventional2021-05-24Recruiting
Open-label Pilot Study of Methylprednisolone for the Treatment of Patients With Friedreich Ataxia (FRDA) [NCT02424435]Early Phase 111 participants (Actual)Interventional2015-06-30Completed
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma [NCT06171932]60 participants (Anticipated)Observational [Patient Registry]2023-11-26Enrolling by invitation
A Pilot Study Examining Selinexor's Ability to Overcome Resistance in Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy. [NCT04519476]Phase 122 participants (Anticipated)Interventional2020-11-01Recruiting
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection [NCT02206789]200 participants (Anticipated)Interventional2012-02-29Recruiting
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768]Phase 2200 participants (Anticipated)Interventional2023-03-09Recruiting
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation. [NCT00903188]Phase 4152 participants (Anticipated)Interventional2008-10-31Recruiting
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis [NCT01011621]Phase 3170 participants (Anticipated)Interventional2010-02-28Not yet recruiting
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses [NCT00984984]Phase 3200 participants (Anticipated)Interventional2008-03-31Recruiting
To Assess the Role of Sphingosine-1-phosphate in the Pathobiology of Pneumonia: Generate a New Strategy for Treatment of Severe Community-acquired Pneumonia [NCT04007328]Phase 2/Phase 3400 participants (Anticipated)Interventional2019-06-15Recruiting
(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy. [NCT00751205]Phase 2150 participants (Actual)Interventional2008-08-31Completed
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment [NCT00977444]Phase 2/Phase 3114 participants (Actual)Interventional2007-11-30Active, not recruiting
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811]Phase 297 participants (Actual)Interventional2004-06-30Completed
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469]Phase 255 participants (Actual)Interventional2004-04-30Completed
A Phase II Study of Panobinostat (LBH589) as Second-Line Therapy in Patients With Chronic Graft-Versus-Host Disease [NCT01028313]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to A decision was made to not move forward with the study. No participants were enrolled or treated.)
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. [NCT00888901]Phase 430 participants (Actual)Interventional2009-05-31Completed
Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation [NCT02540395]184 participants (Actual)Interventional2015-03-31Completed
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445]0 participants (Actual)Observational2008-03-24Withdrawn
Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis [NCT00908089]Phase 4100 participants (Actual)Interventional2003-03-31Active, not recruiting
Corticoids in Severe Community-acquired Pneumonia [NCT00908713]Phase 4120 participants (Actual)Interventional2004-01-31Completed
The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study [NCT02733510]200 participants (Anticipated)Observational2016-04-30Recruiting
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial [NCT05765266]45 participants (Anticipated)Interventional2023-08-12Not yet recruiting
Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study [NCT02711982]2 participants (Anticipated)Interventional2010-01-31Recruiting
Greater Occipital Nerve Block for Migraine Prophylaxis [NCT00915473]Phase 470 participants (Actual)Interventional2009-06-30Completed
A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study [NCT02680548]Early Phase 18 participants (Actual)Interventional2015-11-30Completed
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study [NCT04051203]Phase 135 participants (Anticipated)Interventional2019-02-01Active, not recruiting
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial [NCT04244591]Phase 2/Phase 380 participants (Actual)Interventional2020-01-26Completed
Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial [NCT03973177]Phase 40 participants (Actual)Interventional2019-05-24Withdrawn(stopped due to Covid restrictions on recruitment)
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients [NCT00971893]0 participants (Actual)Observational2009-10-31Withdrawn
A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283]Phase 17 participants (Actual)Interventional2016-01-13Completed
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipi [NCT02763761]Phase 20 participants (Actual)Interventional2016-08-16Withdrawn(stopped due to Insufficient enrollment)
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism and Beta-Cell Dysfunction in Males With the Metabolic Syndrome X: A Randomized, Placebo-controlled, Double-blind Intervention Study With a 2x2 Factorial Design [NCT00721552]82 participants (Actual)Interventional2008-10-31Completed
Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain [NCT00887003]252 participants (Actual)Interventional2005-05-31Completed
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625]Phase 36,720 participants (Anticipated)Interventional2019-07-03Recruiting
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis [NCT01201798]Phase 3111 participants (Actual)Interventional2010-10-31Completed
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172]Phase 216 participants (Actual)Interventional2006-02-28Terminated(stopped due to Competing study was started.)
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation. [NCT00345046]Phase 460 participants (Actual)Interventional2002-09-30Completed
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial [NCT01014104]Phase 1/Phase 2218 participants (Actual)Interventional2009-10-31Completed
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430]Phase 485 participants (Actual)Interventional2007-05-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968903]Phase 448 participants (Actual)Interventional2010-04-30Completed
Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif) [NCT01049451]Phase 123 participants (Actual)Interventional2009-11-30Completed
Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia [NCT02535039]Phase 1/Phase 280 participants (Anticipated)Interventional2015-10-31Recruiting
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00481832]Phase 250 participants (Actual)Interventional2007-01-31Terminated(stopped due to Accrual Factor)
Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial [NCT04377503]Phase 230 participants (Actual)Interventional2020-05-01Terminated(stopped due to The number of critically ill patients wirh COVID-19 decrease abruptly)
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial [NCT00989729]150 participants (Actual)Interventional2009-10-31Completed
Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524]Phase 240 participants (Anticipated)Interventional2020-05-29Recruiting
A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone [NCT00698724]Phase 4200 participants (Anticipated)Interventional2008-06-30Completed
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone [NCT05368181]Phase 256 participants (Anticipated)Interventional2022-05-01Recruiting
Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome [NCT02669303]19 participants (Actual)Interventional2015-09-30Terminated(stopped due to low recruitment rate and high rate of loss-to-followup)
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone) [NCT05438277]Phase 4421 participants (Actual)Interventional2020-01-01Completed
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial [NCT02594241]42 participants (Actual)Interventional2016-03-31Completed
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen [NCT05626478]Phase 4100 participants (Anticipated)Interventional2023-06-01Recruiting
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%. [NCT04521140]Phase 436 participants (Actual)Interventional2020-10-16Completed
Phase II Trial Of Yttrium-90-Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy After Cytoreduction With ESHAP Chemotherapy In Patients With Relapsed Follicular Non-Hodgkin's Lymphoma [NCT00732498]Phase 228 participants (Actual)Interventional2006-05-15Completed
Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis [NCT04103684]Phase 4100 participants (Anticipated)Interventional2020-03-30Not yet recruiting
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial [NCT00802529]Phase 2/Phase 360 participants (Actual)Interventional2009-04-30Completed
"Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol (Albuterol Responders)?" [NCT00798616]0 participants (Actual)InterventionalWithdrawn(stopped due to We were unable to enroll a sufficient number of patients due to manpower.)
Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery. [NCT01227876]Phase 3106 participants (Actual)Interventional2011-01-31Completed
Prospective Comparison of Sirolimus Against Corticosteroids in Treatment of Patients With Active Thyroid Eye Disease [NCT04936854]Phase 260 participants (Anticipated)Interventional2023-01-01Recruiting
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859]Phase 4206 participants (Actual)Interventional1998-05-31Completed
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [NCT00758199]Phase 449 participants (Actual)Interventional2008-07-31Completed
An Observational, Retrospective, Single-center, Clinical Study to Evaluate the Efficacy of Sirolimus (Rapamycin) in Patients With Graves' Disease and Moderate-to-severe and Active Graves' Orbitopathy (GO) [NCT05345119]30 participants (Actual)Observational2020-01-15Completed
Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) [NCT00968253]Phase 1/Phase 224 participants (Actual)Interventional2009-11-30Completed
An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201 [NCT02887976]Phase 32 participants (Actual)Interventional2016-09-30Completed
The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes: An Open-Label, Randomized Clinical Trial [NCT02664493]154 participants (Anticipated)Interventional2016-02-29Recruiting
Treatment of Chronic Subdural Hematoma by Corticosteroids [NCT02650609]Phase 3202 participants (Actual)Interventional2016-06-24Completed
Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study) [NCT02647255]Phase 2/Phase 310 participants (Actual)Interventional2016-03-31Terminated(stopped due to Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.)
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]Phase 429 participants (Actual)Interventional2009-03-31Completed
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients [NCT00782717]Phase 2263 participants (Actual)Interventional2008-11-30Completed
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia [NCT00632554]Phase 450 participants (Anticipated)Interventional2008-06-30Completed
Phase II Trial of the Addition of PEG-Asparaginase to the Hyper-CVAD Regimen in Adult Newly-Diagnosed Acute Lymphoblastic Leukemia [NCT01005914]Phase 211 participants (Actual)Interventional2009-06-30Terminated(stopped due to Increased rate of bacterial infections)
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies [NCT00865540]Phase 430 participants (Actual)Interventional2009-03-31Active, not recruiting
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial [NCT00804531]Phase 4137 participants (Actual)Interventional2009-04-30Completed
Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps [NCT05157412]Phase 360 participants (Anticipated)Interventional2022-03-01Not yet recruiting
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis [NCT04318652]Phase 480 participants (Actual)Interventional2018-09-02Completed
Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy [NCT00596947]Phase 418 participants (Actual)Interventional2005-10-31Terminated(stopped due to due to low study enrollment)
Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1) [NCT02798068]Phase 460 participants (Anticipated)Interventional2016-05-31Recruiting
Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery [NCT04316936]Phase 415 participants (Actual)Interventional2019-12-10Completed
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial [NCT04014634]Phase 480 participants (Anticipated)Interventional2019-08-01Recruiting
A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control [NCT02760316]Phase 164 participants (Anticipated)Interventional2016-05-02Completed
Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China [NCT02757196]Phase 2112 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Budesonide Inhalation Suspension for Acute Asthma in Children [NCT00393367]Phase 4179 participants (Actual)Interventional2006-12-31Completed
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT04220632]Phase 1/Phase 21 participants (Actual)Interventional2020-06-18Terminated(stopped due to Adverse events of the first patient)
A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred [NCT01124045]Phase 380 participants (Actual)Interventional2010-08-31Completed
Intrathecal Rituximab in Progressive Multiple Sclerosis [NCT02545959]Phase 210 participants (Actual)Interventional2015-11-30Completed
Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome [NCT00656110]60 participants (Anticipated)Interventional2008-04-30Recruiting
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial [NCT05058287]Phase 3150 participants (Anticipated)Interventional2021-11-05Recruiting
Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse [NCT00753792]Phase 449 participants (Actual)Interventional2008-11-30Completed
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial [NCT04617561]Phase 490 participants (Anticipated)Interventional2020-11-01Recruiting
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial [NCT00863889]Phase 40 participants (Actual)Interventional2009-03-31Withdrawn
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy: Presentation of a Unique Case [NCT05350384]1 participants (Actual)Observational2021-06-18Completed
Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial [NCT01392833]Phase 346 participants (Actual)Interventional1999-12-31Completed
Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma [NCT02293109]Phase 110 participants (Actual)Interventional2015-12-17Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions [NCT01405157]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions [NCT01405170]Phase 10 participants (Actual)Interventional2011-10-14Withdrawn
A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine [NCT04017741]Phase 48 participants (Actual)Interventional2018-02-14Completed
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis [NCT01408836]Phase 2/Phase 3150 participants (Actual)Interventional1995-03-31Terminated(stopped due to Completed)
Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study [NCT05279482]104 participants (Actual)Observational2022-01-19Completed
A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD) [NCT00609609]Phase 281 participants (Actual)Interventional2008-01-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968578]Phase 448 participants (Actual)Interventional2009-08-31Completed
Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia [NCT00671658]Phase 2220 participants (Actual)Interventional2002-11-30Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty [NCT02542592]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies [NCT01093586]Phase 214 participants (Actual)Interventional2007-09-30Completed
An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia [NCT04263402]Phase 4100 participants (Anticipated)Interventional2020-02-01Recruiting
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease [NCT02614612]Phase 131 participants (Actual)Interventional2015-12-31Completed
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers [NCT00744224]8 participants (Anticipated)Interventional2009-02-28Completed
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol [NCT00991744]Phase 3100 participants (Anticipated)Interventional2009-01-31Suspended(stopped due to Sterility problems in DepoCyte production)
A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+) ALL of Young Adults (18-59 Years Old) (GRAAPH-2014) [NCT02611492]Phase 3265 participants (Anticipated)Interventional2016-04-30Recruiting
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial [NCT04302116]250 participants (Anticipated)Interventional2020-05-18Recruiting
Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy [NCT04219995]Phase 1/Phase 210 participants (Anticipated)Interventional2020-02-03Recruiting
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation [NCT00309907]Phase 239 participants (Actual)Interventional2006-04-30Completed
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis [NCT02717871]Phase 335 participants (Actual)Interventional2016-03-31Completed
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109]Phase 2/Phase 363 participants (Actual)Interventional2008-07-14Completed
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis [NCT01907204]Phase 2/Phase 350 participants (Actual)Interventional2013-07-31Completed
Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Stu [NCT00947895]Phase 2/Phase 330 participants (Actual)Interventional2009-10-31Terminated(stopped due to Study reached halfway point in approximately one year time period and was halted to analyze data.)
Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen [NCT03578276]Phase 435 participants (Actual)Interventional2018-06-22Completed
[NCT00000147]0 participants Interventional1988-07-31Active, not recruiting
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) [NCT00000579]Phase 30 participants Interventional1994-09-30Completed
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients [NCT00000741]Phase 30 participants (Actual)InterventionalWithdrawn
"Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine" [NCT00796250]Phase 39 participants (Actual)Interventional2003-11-01Terminated(stopped due to Due to poor patient recruitment, a decision was made to terminate this trial.)
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC [NCT02944045]Phase 3222 participants (Anticipated)Interventional2017-02-15Recruiting
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial [NCT02552342]Phase 4610 participants (Anticipated)Interventional2015-05-31Recruiting
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis [NCT02406209]Phase 245 participants (Actual)Interventional2015-03-31Completed
Acute Unilateral Vestibulopathy and Corticosteroid Treatment [NCT02912182]Phase 478 participants (Actual)Interventional2015-12-31Terminated(stopped due to Placebo medication expired)
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01024322]1,189 participants (Actual)Observational2009-10-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Utility of Intramuscular Corticosteroids for Radicular Low Back Pain [NCT00290589]Phase 382 participants (Actual)Interventional2003-06-30Completed
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial [NCT03742466]50 participants (Actual)Interventional2018-11-10Completed
A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib [NCT01324596]Phase 31,132 participants (Actual)Interventional2011-04-30Completed
A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare [NCT00423098]Phase 281 participants (Actual)Interventional2007-02-28Completed
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation [NCT00186628]Phase 236 participants (Actual)Interventional2005-06-30Completed
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral [NCT01046786]Phase 1/Phase 28 participants (Actual)Interventional2010-01-31Completed
An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial [NCT05097976]Phase 4420 participants (Anticipated)Interventional2022-03-01Recruiting
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis [NCT00332696]Phase 264 participants (Actual)Interventional2005-09-30Completed
A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation [NCT01095172]Phase 4100 participants (Actual)Interventional2010-11-30Active, not recruiting
High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial [NCT00278564]Phase 17 participants (Actual)Interventional2005-09-30Terminated(stopped due to high relapse rate)
An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects [NCT01886209]Phase 128 participants (Anticipated)Interventional2013-06-30Completed
Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE) [NCT04380857]Phase 420 participants (Actual)Interventional2020-06-18Completed
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease [NCT00410657]Phase 253 participants (Anticipated)Interventional2006-07-31Completed
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial [NCT01939691]Phase 49 participants (Actual)Interventional2018-09-12Terminated(stopped due to Difficulty enrolling)
A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study [NCT00241254]Phase 3138 participants (Actual)Interventional2005-12-31Completed
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Itolizumab in Subjects With Newly Diagnosed Acute Graft Versus Host Disease [NCT05823675]Phase 144 participants (Anticipated)Interventional2023-05-19Recruiting
Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia [NCT00558181]Phase 229 participants (Actual)Interventional2007-09-30Completed
European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) [NCT01955187]Phase 386 participants (Actual)Interventional2014-01-31Completed
Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings [NCT01957631]Phase 2/Phase 30 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to Lack of funding)
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019]Phase 470 participants (Anticipated)Interventional2010-01-31Recruiting
Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial [NCT01974024]Phase 365 participants (Actual)Interventional2013-10-01Completed
A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis [NCT01983527]132 participants (Anticipated)Interventional2013-12-31Not yet recruiting
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis [NCT01986465]Phase 2/Phase 378 participants (Actual)Interventional2013-05-31Completed
Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. [NCT01986998]Phase 449 participants (Actual)Interventional2013-10-31Completed
Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof. [NCT01994759]Phase 490 participants (Actual)Interventional2013-09-01Completed
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease [NCT04603729]Phase 3100 participants (Actual)Interventional2020-05-30Completed
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia [NCT01995019]Phase 456 participants (Actual)Interventional2013-12-10Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial [NCT01997658]Phase 2/Phase 3200 participants (Actual)Interventional2014-10-31Completed
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children [NCT02002078]Phase 483 participants (Actual)Interventional2007-02-28Completed
Efficacy of the Intralesional Infusion of Local Anesthetic and Steroids After Major Abdominal Surgery: a Randomized Double Blind Phase III Trial [NCT02002663]Phase 3120 participants (Actual)Interventional2013-08-31Completed
Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS) [NCT02038452]Phase 4234 participants (Actual)Interventional2014-04-30Completed
Influence of Corticoids on Renal Function in Cardiac Surgery [NCT00879931]Phase 280 participants (Actual)Interventional2013-01-31Completed
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT00934843]77 participants (Actual)Interventional2007-03-31Completed
Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial [NCT02539394]128 participants (Actual)Interventional2015-08-31Completed
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial [NCT03265405]Phase 486 participants (Actual)Interventional2017-04-01Completed
Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery. [NCT04631315]Phase 4255 participants (Actual)Interventional2019-03-24Completed
Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study [NCT04601142]350 participants (Anticipated)Observational2020-10-31Recruiting
Peking University Third Hospital Medical Science Research Ethics Committee [NCT04590183]30 participants (Anticipated)Interventional2020-10-01Recruiting
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroid [NCT01085097]Phase 246 participants (Actual)Interventional2010-09-01Completed
The Efficacy Of Magnesium In Radicular Lower Limb Pain When It Is Added To Local Anesthetics And Steroids In The Transforaminal Epidural Injections. A Comparative Study [NCT04532775]Phase 1100 participants (Anticipated)Interventional2020-08-30Not yet recruiting
Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement [NCT04528797]199 participants (Actual)Interventional2010-09-02Completed
Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial. [NCT06045013]Phase 370 participants (Anticipated)Interventional2023-09-13Recruiting
Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study [NCT06081101]Early Phase 180 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial [NCT01607580]145 participants (Actual)Interventional2012-06-30Completed
Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally [NCT05649878]8 participants (Actual)Interventional2021-11-05Completed
Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial [NCT00600639]Phase 482 participants (Actual)Interventional2004-01-31Terminated
Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment [NCT00806871]Phase 2/Phase 3112 participants (Actual)Interventional2008-11-30Completed
Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis [NCT00424489]Phase 19 participants (Actual)Interventional2002-02-28Terminated(stopped due to No participants enrolled for more than two years. No plan to continue study.)
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study [NCT04168112]Phase 420 participants (Actual)Interventional2020-02-12Completed
Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals [NCT00713440]10 participants (Actual)Interventional2008-07-31Completed
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171]Phase 278 participants (Anticipated)Interventional2023-11-20Recruiting
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy [NCT02711449]Phase 278 participants (Actual)Interventional2016-04-30Completed
An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura [NCT04074187]Phase 2/Phase 321 participants (Actual)Interventional2019-10-21Completed
A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury [NCT02651350]Phase 1/Phase 280 participants (Actual)Interventional2015-12-31Completed
Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery [NCT02867904]Phase 412 participants (Actual)Interventional2016-03-31Terminated(stopped due to It was difficult to recruit patients to get the appropriate sample size.)
Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial [NCT04163536]Phase 3440 participants (Anticipated)Interventional2021-10-25Recruiting
Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation [NCT00908583]Phase 444 participants (Actual)Interventional2009-05-31Completed
Corticosteroids for Cancer Pain [NCT00676936]Phase 350 participants (Actual)Interventional2008-04-30Completed
A Randomized Trial of Cortisone Injection Versus Bone Marrow Aspirate Injection Therapy for Glenohumeral Osteoarthritis [NCT03580148]Phase 2/Phase 334 participants (Actual)Interventional2015-10-08Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01405131]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery [NCT00438087]Phase 3313 participants (Actual)Interventional2007-03-31Completed
Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome [NCT01423864]Phase 229 participants (Actual)Interventional2005-06-30Completed
Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study [NCT04765371]Phase 389 participants (Actual)Interventional2021-03-03Completed
A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients [NCT04673162]Phase 3260 participants (Actual)Interventional2020-12-17Completed
Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. [NCT02921555]Phase 475 participants (Actual)Interventional2018-10-11Completed
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment [NCT04464629]Phase 47 participants (Actual)Interventional2020-07-14Terminated(stopped due to Poor enrollment)
A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation [NCT00694408]Phase 315 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study terminated due to withdrawal from market of Daclizumab)
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067]Phase 310 participants (Actual)Interventional2008-04-30Terminated(stopped due to Italian Medicines Agency decision)
Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis Wi [NCT00185510]Phase 4250 participants (Actual)Interventional2005-03-31Completed
Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma? [NCT00213252]Phase 2130 participants (Actual)Interventional2005-09-30Completed
Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study [NCT04898231]Phase 2/Phase 3180 participants (Anticipated)Interventional2020-12-22Active, not recruiting
A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failur [NCT04862221]Phase 2163 participants (Anticipated)Interventional2022-02-09Recruiting
Comparison of the Efficacy and Safety of Two Corticosteroid Regimens in the Treatment of Diffuse Lung Disease After Coronavirus Disease 2019 (COVID-19) Pneumonia [NCT04657484]130 participants (Actual)Interventional2020-12-01Completed
Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial [NCT05015322]Phase 488 participants (Actual)Interventional2017-01-01Completed
Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology [NCT02416128]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to No participants enrolled)
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal I [NCT02956122]Phase 2/Phase 31 participants (Actual)Interventional2017-04-26Terminated(stopped due to The decision to discontinue the study was based on business reasons.)
[NCT00000138]Phase 30 participants Interventional1989-05-31Active, not recruiting
High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma - a Phase II Study [NCT00455286]Phase 225 participants Interventional2006-11-30Recruiting
Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass [NCT00427388]Phase 47,507 participants (Actual)Interventional2007-06-30Active, not recruiting
[NCT00480675]65 participants (Actual)Interventional2007-03-31Completed
[NCT00469781]Phase 495 participants (Actual)Interventional2007-05-31Completed
[NCT00501579]Phase 30 participants InterventionalCompleted
A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal [NCT01244334]Phase 452 participants (Actual)Interventional2009-03-31Completed
A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial). [NCT05851508]Phase 3148 participants (Anticipated)Interventional2023-10-01Recruiting
Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care [NCT05638633]Phase 3340 participants (Anticipated)Interventional2022-11-11Recruiting
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358]Phase 278 participants (Actual)Interventional2017-04-01Active, not recruiting
Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance [NCT00752479]Phase 1/Phase 24 participants (Actual)Interventional2008-05-31Terminated(stopped due to Necessity of major revision of the protocol)
Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy [NCT00523692]Phase 420 participants (Anticipated)Interventional2007-09-30Not yet recruiting
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy [NCT00510263]Phase 4839 participants (Actual)Interventional2001-05-31Completed
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants [NCT02935101]Phase 24 participants (Actual)Interventional2016-10-31Terminated(stopped due to difficulties in recruiting study participants)
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms [NCT02932020]0 participants (Actual)Interventional2016-10-31Withdrawn
A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01267201]Phase 124 participants (Actual)Interventional2010-11-30Completed
Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study [NCT04681937]80 participants (Anticipated)Interventional2021-06-01Not yet recruiting
High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab [NCT01211665]Phase 43 participants (Actual)Interventional2010-09-30Terminated(stopped due to This study was stopped prematurely due to lack of enrollment within a 1-5-year period.)
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study [NCT04351737]Phase 420 participants (Anticipated)Interventional2020-07-15Active, not recruiting
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380]Phase 1/Phase 20 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to Withdrawn per CS0150757)
Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture [NCT05655130]Phase 160 participants (Anticipated)Interventional2018-11-06Active, not recruiting
An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE) [NCT01219933]Phase 468 participants (Actual)Interventional2011-01-31Completed
[NCT00854061]Phase 3172 participants (Actual)Interventional2009-02-28Completed
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00882895]Phase 218 participants (Actual)Interventional2009-05-05Active, not recruiting
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm [NCT04355247]Phase 220 participants (Anticipated)Interventional2020-04-14Recruiting
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies [NCT00003960]Phase 236 participants (Anticipated)Interventional1998-04-30Completed
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation [NCT00357084]Phase 253 participants (Anticipated)Interventional2006-05-31Completed
Research on the Treatment of Severe Community-acquired Pneumonia in Children [NCT05768204]Phase 4160 participants (Anticipated)Interventional2023-03-10Recruiting
Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica [NCT01482897]Phase 313 participants (Actual)Interventional2011-12-31Terminated(stopped due to Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).)
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans [NCT00281710]Phase 420 participants Interventional2005-10-31Completed
Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START) [NCT00290602]Phase 240 participants Interventional2004-02-29Completed
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma [NCT00307606]Phase 440 participants (Anticipated)Interventional2005-12-31Recruiting
The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial [NCT00312520]Phase 320 participants Interventional2002-07-31Completed
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus [NCT04233164]Early Phase 147 participants (Actual)Interventional2020-03-04Active, not recruiting
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment [NCT05665270]Phase 440 participants (Anticipated)Interventional2023-01-30Enrolling by invitation
[NCT00433225]Phase 40 participants InterventionalCompleted
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients [NCT00348244]Phase 40 participants InterventionalCompleted
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monothe [NCT00112034]Phase 4350 participants Interventional2003-06-30Completed
Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis [NCT00480298]Phase 248 participants Interventional2002-11-30Completed
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study. [NCT00481819]Phase 3240 participants (Actual)Interventional2007-07-31Completed
The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome [NCT00127985]Phase 4240 participants (Anticipated)Interventional2005-08-31Recruiting
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship [NCT00134693]Phase 277 participants (Actual)Interventional2005-06-21Completed
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy [NCT00135122]Phase 3100 participants (Actual)Interventional2003-09-30Completed
Assessment of the Efficacy of Glucocorticoids in Improving Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection(GLAD): a Randomized Controlled Trial [NCT05329740]Phase 4212 participants (Actual)Interventional2022-02-07Completed
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache [NCT05324748]Phase 350 participants (Anticipated)Interventional2022-11-07Recruiting
A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability，Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia [NCT05302388]Phase 145 participants (Actual)Interventional2022-04-11Completed
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586]Phase 3244 participants (Anticipated)Interventional2021-10-05Recruiting
The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study [NCT02784210]Phase 230 participants (Anticipated)Interventional2016-10-05Recruiting
A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma [NCT00004192]Phase 260 participants (Anticipated)Interventional2000-05-01Completed
Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis [NCT01773616]Phase 324 participants (Actual)Interventional2015-04-30Terminated(stopped due to Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.)
Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease [NCT00787722]Phase 1/Phase 213 participants (Actual)Interventional2009-10-10Completed
Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome [NCT00806598]Phase 253 participants (Actual)Interventional2005-05-31Completed
A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies [NCT02464696]256 participants (Anticipated)Interventional2015-10-06Recruiting
Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) [NCT01105650]Phase 213 participants (Actual)Interventional2010-07-31Completed
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference? [NCT04693312]Phase 2/Phase 360 participants (Actual)Interventional2020-01-01Completed
Multi-center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular [NCT00170729]Phase 462 participants (Actual)Interventional2004-08-17Completed
The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study [NCT04653415]Phase 4160 participants (Actual)Interventional2019-06-01Completed
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018]Phase 13 participants (Actual)Interventional2012-02-22Active, not recruiting
A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease [NCT00929695]Phase 3164 participants (Actual)Interventional2009-06-30Completed
CSP #574 - Evaluate the Safety and Efficacy of Methylprednisolone in Hospitalized Veterans With Severe Community-Acquired Pneumonia [NCT01283009]Phase 3584 participants (Actual)Interventional2012-01-09Completed
Comparison of Efficacy and Safety of Intravenous Pulsed Methylprednisolone and Oral Methotrexate Versus Intravenous Pulsed Methylprednisolone and Oral Placebo in the Treatment of Active Moderate and Severe Thyroid Eye Disease - a Prospective, Randomized, [NCT00348413]80 participants (Anticipated)Interventional2003-06-30Completed
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation [NCT05461261]Phase 250 participants (Anticipated)Interventional2022-07-01Recruiting
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study [NCT03415828]83 participants (Actual)Interventional2018-05-29Active, not recruiting
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study). [NCT01529320]Phase 118 participants (Actual)Interventional2012-02-29Completed
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease [NCT00109993]Phase 234 participants (Actual)Interventional2005-01-31Completed
[NCT00000146]Phase 30 participants Interventional1988-07-31Active, not recruiting
[NCT02115997]Phase 430 participants (Actual)Interventional2015-07-06Completed
[NCT00017628]Phase 120 participants Interventional2001-04-30Completed
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr [NCT00043147]Phase 30 participants Interventional2002-04-30Completed
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study [NCT00135967]Phase 2/Phase 330 participants Interventional2002-05-31Completed
Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of [NCT00138970]Phase 470 participants Interventional2002-01-31Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membra [NCT00404794]Phase 320 participants (Anticipated)Interventional2005-11-30Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) [NCT00404833]Phase 316 participants (Anticipated)Interventional2003-01-31Completed
Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone [NCT00396747]Phase 445 participants (Actual)Interventional2003-06-30Completed
A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy [NCT03098225]Phase 4120 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF [NCT04702256]Phase 3196 participants (Anticipated)Interventional2021-12-09Recruiting
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo [NCT00053976]Phase 3105 participants (Actual)Interventional2001-01-31Completed
Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers [NCT00134992]Phase 430 participants Interventional2004-08-31Completed
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty [NCT00406042]25 participants Interventional2005-09-30Completed
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease [NCT00152620]40 participants Interventional2004-06-30Terminated(stopped due to study completed)
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT00053105]Phase 10 participants Interventional2002-02-28Active, not recruiting
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension [NCT00198523]Phase 3132 participants Interventional2005-07-31Completed
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial. [NCT00199576]Phase 3670 participants Interventional2000-12-31Completed
the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial [NCT01792037]Phase 490 participants (Actual)Interventional2012-12-31Completed
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery [NCT04200651]Phase 425 participants (Actual)Interventional2020-01-13Completed
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874]Phase 2297 participants (Actual)Interventional2011-08-24Completed
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973]101 participants (Actual)Interventional2006-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension [NCT00521989]Phase 2279 participants (Actual)Interventional2007-08-31Terminated(stopped due to CRx-102-006 study results, negative)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) [NCT00551707]Phase 251 participants (Actual)Interventional2007-10-31Completed
A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AM [NCT00568633]Phase 358 participants (Actual)Interventional2007-08-31Terminated(stopped due to Poor accrual)
Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials [NCT03152474]Phase 4300 participants (Actual)Interventional1993-02-28Completed
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis [NCT00682357]25 participants (Actual)Interventional2008-05-31Completed
Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients [NCT01277731]0 participants (Actual)Interventional2010-07-31Withdrawn
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549]Phase 266 participants (Anticipated)Interventional2023-02-07Recruiting
[NCT00699803]Phase 264 participants (Actual)Interventional2008-05-31Completed
Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children [NCT01272635]Phase 3607 participants (Actual)Interventional2011-03-31Completed
An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression [NCT04345445]Phase 3310 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections. [NCT01726465]Phase 250 participants (Actual)Interventional2012-11-30Terminated(stopped due to The first phase was completed)
Efficacy and Safety Evaluation of Rapamycin Combined With Methylprednisolone in the Treatment of Hyperthyroidism Exophthalmos: A Randomized, Controlled, Multicenter Clinical Trial. [NCT05532072]Early Phase 1140 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial [NCT03958344]Phase 3120 participants (Anticipated)Interventional2022-01-01Recruiting
Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome [NCT02652390]Phase 4111 participants (Actual)Interventional2016-02-29Completed
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial [NCT04559113]200 participants (Anticipated)Interventional2020-05-01Recruiting
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation [NCT02212210]Early Phase 1135 participants (Actual)Interventional2012-02-29Terminated(stopped due to PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed)
The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial [NCT04177433]Phase 490 participants (Anticipated)Interventional2020-12-02Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multipl [NCT02217631]Phase 1140 participants (Actual)Interventional2009-10-31Completed
A Proof of Concept Study to Determine the Local Delivery and Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue in Subjects With Peripheral Artery Disease. [NCT01647685]Phase 1/Phase 221 participants (Anticipated)Interventional2012-05-31Recruiting
Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery [NCT01603030]Phase 366 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial [NCT01603498]18 participants (Actual)Interventional2011-04-30Completed
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis [NCT00299013]Phase 3796 participants (Actual)Interventional2006-03-31Completed
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671]Phase 4108 participants (Actual)Interventional2005-07-31Completed
A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease [NCT00282503]Phase 319 participants (Actual)Interventional2006-01-31Terminated(stopped due to Lack of recruitment)
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease [NCT00311961]Phase 4256 participants Interventional2001-06-30Completed
Long Term Tapering or Standard Steroids for Nephrotic Syndrome [NCT00308321]Phase 450 participants (Anticipated)Interventional2003-09-30Recruiting
Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF) [NCT00309218]Phase 342 participants (Actual)Interventional1999-03-31Completed
Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study [NCT06163755]Phase 20 participants (Actual)Interventional2018-01-01Withdrawn(stopped due to Lack of funding)
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211]Phase 2670 participants (Anticipated)Interventional2022-09-06Recruiting
Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up [NCT01499641]200 participants (Actual)Interventional2001-05-31Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspen [NCT01505088]Phase 3193 participants (Actual)Interventional2011-12-31Completed
The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer [NCT01506804]99 participants (Actual)Interventional2010-11-30Completed
[NCT01627236]120 participants (Anticipated)Interventional2012-12-31Recruiting
Targeting Iatrogenic Cushing's Syndrome With 11β-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI) [NCT03111810]Phase 232 participants (Actual)Interventional2017-05-25Completed
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation: a Randomized Study [NCT01640743]58 participants (Actual)Interventional2010-03-31Completed
Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis [NCT01652417]40 participants (Actual)Interventional2012-10-31Terminated(stopped due to insufficient recruitment)
The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis [NCT05291793]80 participants (Actual)Interventional2020-04-01Completed
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model [NCT00689078]Phase 436 participants (Actual)Interventional2008-05-31Completed
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study [NCT01275638]Phase 455 participants (Actual)Interventional2005-04-30Completed
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041]Phase 224 participants (Actual)Interventional2014-07-11Terminated(stopped due to The study was halted early due to slow accrual.)
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. [NCT01694134]Phase 350 participants (Actual)Interventional2012-07-12Completed
Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study [NCT02444429]Phase 3346 participants (Anticipated)Interventional2015-09-30Recruiting
Alternative Treatment Paradigm for Natalizumab Trial [NCT01710228]Phase 20 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to sponsor stopped)
Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study [NCT01742338]Phase 4125 participants (Anticipated)Interventional2012-05-03Suspended(stopped due to The study has been suspended to address research staffing and the feasibility of continued recruitment)
Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement [NCT01755338]30 participants (Actual)Interventional2012-12-31Completed
Phase II, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children [NCT01757899]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Technical problems)
A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to Validate the Cantharidin Blister Model in Healthy Male Volunteers [NCT01762787]Phase 140 participants (Actual)Interventional2010-08-17Completed
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone [NCT01789892]0 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to no patient accrual)
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica [NCT01816334]Phase 450 participants (Actual)Interventional2013-01-31Completed
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial [NCT01828437]Phase 362 participants (Actual)Interventional2012-11-30Completed
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Perineural Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain: The Resperist Study [NCT03009500]Phase 33 participants (Actual)Interventional2017-01-31Completed
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847]Phase 1/Phase 2117 participants (Actual)Interventional2015-02-28Completed
A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357]Phase 245 participants (Anticipated)Interventional2014-12-31Terminated(stopped due to Early termination due to the difficulties to enroll subjects.)
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint [NCT03232749]Phase 425 participants (Actual)Interventional2018-04-18Terminated(stopped due to The physician in charge is leaving the University of Florida)
Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis [NCT01809132]Phase 2/Phase 3104 participants (Actual)Interventional2013-09-30Completed
SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia [NCT03852537]Phase 244 participants (Actual)Interventional2019-12-02Completed
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncolo [NCT00553202]Phase 2158 participants (Actual)Interventional2008-01-31Completed
Towards a Self-Administered Hearing Protection Regimen [NCT04826237]Phase 4100 participants (Anticipated)Interventional2023-02-09Recruiting
Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial. [NCT04343729]Phase 2416 participants (Actual)Interventional2020-04-18Completed
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) [NCT04826588]Phase 376 participants (Actual)Interventional2021-05-23Completed
A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) [NCT02296346]13 participants (Actual)Interventional2014-10-31Terminated(stopped due to Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer)
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% [NCT01437982]Phase 4140 participants (Anticipated)Interventional2010-08-05Completed
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis [NCT05734625]Phase 260 participants (Anticipated)Interventional2023-07-10Recruiting
The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER) [NCT05620901]Early Phase 130 participants (Anticipated)Interventional2023-02-01Recruiting
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255]Phase 480 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated/Fulminant Acute Myocarditis [NCT05150704]Phase 3288 participants (Anticipated)Interventional2021-10-07Recruiting
Randomized Multicenter Phase 3 Single-blind Trial Comparing the Efficacy of Corticosteroid Control to Mesenchymal Stem Cell Preparations From Autologous Bone Marrow Concentrate (BMAC), Adipose-derived Stem Cells in the Form of Stromal Vascular Fraction (S [NCT03818737]Phase 3475 participants (Actual)Interventional2019-03-28Completed
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation [NCT06076824]Phase 4100 participants (Anticipated)Interventional2023-08-12Recruiting
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease [NCT04988282]Phase 4262 participants (Actual)Interventional2021-05-24Completed
Early Short Course Corticosteroids in Hospitalized Patients With COVID-19 [NCT04374071]250 participants (Actual)Observational2020-03-12Completed
Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects [NCT00929981]80 participants (Actual)Observational2009-09-30Completed
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy [NCT03018535]Phase 376 participants (Actual)Interventional2012-01-31Active, not recruiting
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy [NCT03122847]30 participants (Anticipated)Observational2017-06-07Active, not recruiting
Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis. [NCT00947765]Phase 2/Phase 360 participants (Actual)Interventional2007-01-31Completed
Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction [NCT03593902]Phase 2/Phase 39 participants (Actual)Interventional2018-05-17Terminated(stopped due to PI Sabbatical)
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone [NCT04744623]Phase 2/Phase 310 participants (Actual)Interventional2020-09-30Active, not recruiting
Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome [NCT04323592]173 participants (Actual)Observational [Patient Registry]2020-03-23Completed
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial [NCT02303587]424 participants (Actual)Interventional2014-12-31Completed
Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study [NCT03797872]Phase 41 participants (Actual)Interventional2019-04-17Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty [NCT02332629]Phase 370 participants (Actual)Interventional2015-01-31Completed
Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy [NCT02167217]Phase 225 participants (Actual)Interventional2014-04-17Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis [NCT05749666]Phase 350 participants (Anticipated)Interventional2023-01-20Recruiting
Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study [NCT00003682]Phase 3160 participants (Anticipated)Interventional1998-10-31Terminated(stopped due to lack of inclusions)
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448]Phase 3255 participants (Actual)Interventional2004-12-31Completed
Phase II Trial of Natalizumab (Tysabri®) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract [NCT02176031]Phase 221 participants (Actual)Interventional2015-01-31Completed
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) [NCT03229538]Phase 31,263 participants (Actual)Interventional2017-10-18Completed
A Randomised, Comparator Controlled, Two Part, Open-label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Doses of Otelixizumab in Patients With Thyroid Orbitopathy [NCT01114503]Phase 22 participants (Actual)Interventional2010-07-07Terminated(stopped due to Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies.)
Single Center, Randomized, Double-Blind, Placebo-Controlled Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab [NCT01144143]Phase 416 participants (Actual)Interventional2007-07-31Completed
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study [NCT04129697]30 participants (Anticipated)Interventional2020-01-01Not yet recruiting
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy [NCT05793359]62 participants (Actual)Observational [Patient Registry]2017-07-25Completed
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails [NCT04273321]86 participants (Actual)Interventional2020-02-14Completed
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial. [NCT04942002]Phase 2/Phase 350 participants (Anticipated)Interventional2021-06-15Recruiting
Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract [NCT01475643]Phase 3107 participants (Actual)Interventional2013-06-30Completed
Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia [NCT01319981]Phase 231 participants (Actual)Interventional2013-03-05Completed
Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids [NCT04426734]Phase 430 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial [NCT02995083]Early Phase 10 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to Study deemed not feasible)
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092]Phase 2250 participants (Anticipated)Interventional2022-09-08Recruiting
Oral Prednisolone Dosing in Children Hospitalized With Asthma [NCT00257933]Phase 4152 participants (Actual)Interventional2006-02-28Completed
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561]Phase 2/Phase 318 participants (Anticipated)Interventional2022-04-05Recruiting
Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid [NCT05339542]98 participants (Actual)Interventional2022-03-10Completed
Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery [NCT01559675]121 participants (Actual)Interventional2010-09-30Completed
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes [NCT04977427]Phase 4200 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. [NCT05587673]Phase 130 participants (Anticipated)Interventional2022-10-06Recruiting
Comparison of Efficacy and Safety of Two Different Ultrasound-Guided Suprascapular Nerve Block Techniques in Chronic Shoulder Pain: A Prospective Double-Blinded Randomized Controlled Study [NCT04938037]80 participants (Anticipated)Interventional2021-06-01Recruiting
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus [NCT03054259]Phase 230 participants (Anticipated)Interventional2017-09-21Recruiting
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery [NCT04393207]Phase 4300 participants (Anticipated)Interventional2022-02-01Recruiting
Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery [NCT04371445]Phase 430 participants (Anticipated)Interventional2020-12-01Enrolling by invitation
Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients [NCT05487521]Phase 393 participants (Actual)Interventional2020-02-20Completed
Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy [NCT04810819]110 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease [NCT05510323]Phase 3208 participants (Anticipated)Interventional2022-08-31Not yet recruiting
The Effectiveness of Pulsed Radiofrequency of the Suprascapular Nerve and Shoulder Joint Compared to Intra-articular Corticosteroid Injection for Hemiplegic Shoulder Pain Management and Functional Improvement. [NCT05563571]20 participants (Anticipated)Interventional2022-04-01Recruiting
DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery [NCT04362241]Phase 430 participants (Anticipated)Interventional2020-08-07Recruiting
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy [NCT01579539]Phase 318 participants (Actual)Interventional2013-06-27Completed
Pre-operative Intravenous Steroid in Unilateral Primary Total Knee Replacement for Pain Relief and Recovery: A Double-Blind Randomized Controlled Trial [NCT03082092]Phase 460 participants (Actual)Interventional2017-06-01Completed
Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) [NCT03829566]Phase 2/Phase 30 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Discontinued by Investigator)
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment [NCT02283996]Phase 4260 participants (Anticipated)Interventional2014-11-30Recruiting
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study [NCT01790022]Phase 220 participants (Actual)Interventional2012-07-31Active, not recruiting
Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older [NCT01238536]Phase 4400 participants (Actual)Interventional2011-04-30Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01872611]Phase 3819 participants (Actual)Interventional2013-06-30Completed
Comparison of Intraarticular Platelet-rich Plasma Injections With Intraarticular Corticosteroid Injections in the Treatment of Primary Knee Osteoarthritis : A Randomized Control Trial [NCT01923909]Phase 40 participants (Actual)Interventional2013-04-30Withdrawn(stopped due to No participants enrolled)
Biomarkers of Lupus Disease: Study of Biomarker Changes Before and After Treatment With Depomedrol and Background Medication Withdrawal in Patients With Mild to Moderate SLE Disease Activity [NCT00987831]Phase 1/Phase 2158 participants (Actual)Interventional2009-05-31Completed
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Relapsed or Refractory CLL/SLL The HiLOG Trial [NCT01497496]Phase 229 participants (Actual)Interventional2012-01-26Completed
Dextenza in Pterygium Surgery [NCT04403516]Phase 430 participants (Actual)Interventional2020-10-01Completed
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen [NCT02515045]Phase 459 participants (Actual)Interventional2015-01-31Completed
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction [NCT02256969]Phase 445 participants (Actual)Interventional2014-10-31Completed
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery [NCT05248139]100 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis [NCT00004357]Phase 26 participants (Actual)Interventional1997-09-30Completed
Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury [NCT00004759]Phase 3497 participants Interventional1991-12-31Completed
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure [NCT02006706]Phase 315 participants (Actual)Interventional2006-08-10Completed
Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee [NCT01216631]Phase 21 participants (Actual)Interventional2010-09-30Terminated(stopped due to Unable to recruit)
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study [NCT02909335]Phase 30 participants (Actual)Interventional2016-11-30Withdrawn
Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections [NCT02576249]Phase 429 participants (Actual)Interventional2015-10-31Completed
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome [NCT00370799]Early Phase 1240 participants (Actual)Interventional2007-01-31Completed
A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity [NCT02466581]Phase 425 participants (Actual)Interventional2015-02-03Active, not recruiting
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome [NCT05349071]158 participants (Anticipated)Interventional2022-05-01Not yet recruiting
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease [NCT01977781]Phase 140 participants (Actual)Interventional2013-12-31Completed
Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis. [NCT05990894]248 participants (Actual)Observational2018-01-01Completed
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021]Phase 3743 participants (Actual)Interventional2012-12-31Completed
High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial [NCT03403517]Phase 4174 participants (Actual)Interventional2017-12-11Completed
Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age [NCT03596723]Phase 32 participants (Actual)Interventional2018-07-03Terminated(stopped due to NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.)
Post-operative Methylprednisolone Taper Course for Orthopedic Surgery [NCT03661645]Phase 41,000 participants (Anticipated)Interventional2018-09-07Enrolling by invitation
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
[NCT00004785]Phase 354 participants Interventional1995-11-30Completed
Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) [NCT02464657]Phase 1/Phase 244 participants (Actual)Interventional2015-07-31Completed
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19 [NCT04341038]Phase 384 participants (Anticipated)Interventional2020-04-01Recruiting
Physiologic Effects of Stress Dose Corticosteroids in the Management of Inhospital Cardiac Arrest - CORTICA [NCT02790788]Phase 1/Phase 2100 participants (Actual)Interventional2016-11-04Completed
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension [NCT03123614]Phase 4131 participants (Actual)Interventional2014-09-19Completed
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge ( [NCT01534195]Phase 411 participants (Actual)Interventional2012-01-31Completed
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial [NCT04438980]Phase 372 participants (Actual)Interventional2020-05-15Completed
Combined Radiotherapy and Intravenous Steroids for Early Progressive Thyroid Eye Disease [NCT02339142]Phase 4100 participants (Anticipated)Interventional2015-01-31Not yet recruiting
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis [NCT03324503]8 participants (Actual)Interventional2017-12-08Completed
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population [NCT04980105]Phase 3150 participants (Actual)Interventional2020-03-02Active, not recruiting
Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial. [NCT03059979]Early Phase 130 participants (Anticipated)Interventional2017-01-31Recruiting
Second Affiliated Hospital, College of Medicine, Zhejiang University [NCT04918953]Phase 290 participants (Anticipated)Interventional2021-06-02Not yet recruiting
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma [NCT03045471]50 participants (Anticipated)Observational2017-03-01Not yet recruiting
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls [NCT04791345]Phase 150 participants (Anticipated)Interventional2021-02-26Recruiting
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study) [NCT04757740]Phase 494 participants (Anticipated)Interventional2021-03-01Recruiting
The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps [NCT02569437]Phase 249 participants (Actual)Interventional2014-09-30Terminated(stopped due to A high percentage of patients were dropping out of the study and were not able to complete the protocol.)
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study [NCT02412059]200 participants (Actual)Interventional2015-08-31Completed
Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery [NCT04480775]Phase 2/Phase 384 participants (Actual)Interventional2020-07-15Completed
Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group [NCT02375867]Phase 433 participants (Actual)Interventional2015-01-31Completed
Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) [NCT02769689]Phase 456 participants (Anticipated)Interventional2019-06-12Recruiting
Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study [NCT02425813]Phase 20 participants (Actual)Interventional2015-10-31Withdrawn(stopped due to Slow Accrual)
Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia [NCT05133635]Phase 40 participants (Actual)Interventional2021-02-01Withdrawn(stopped due to A recent study suggested a new corticosteroid regime for intensive care unit patients.)
Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement [NCT03160651]140 participants (Anticipated)Interventional2018-02-09Recruiting
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study [NCT05914350]105 participants (Anticipated)Interventional2023-06-23Recruiting
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone [NCT04900220]Phase 466 participants (Actual)Interventional2021-09-15Completed
Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids [NCT02798523]Phase 133 participants (Actual)Interventional2017-01-24Completed
Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain [NCT02334475]40 participants (Actual)Interventional2013-07-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty [NCT02332603]Phase 3134 participants (Actual)Interventional2015-01-31Completed
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution [NCT05002517]Phase 360 participants (Anticipated)Interventional2020-09-03Active, not recruiting
Antiviral Treatment in Facial Palsy. Randomized Control Trial [NCT02328079]50 participants (Actual)Interventional2013-04-30Completed
Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty [NCT01448213]Phase 2264 participants (Actual)Interventional2011-10-31Completed
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome [NCT00128180]Phase 266 participants (Actual)Interventional2003-01-31Completed
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma [NCT00248534]Phase 216 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual/lack of resources/low priority due to combining 2 consortia)
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy [NCT01652495]Phase 444 participants (Actual)Interventional2012-03-31Completed
A Phase 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237]Phase 1/Phase 23 participants (Actual)Interventional2013-12-27Terminated
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty [NCT01853696]Phase 4167 participants (Actual)Interventional2013-03-31Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01853072]Phase 3881 participants (Actual)Interventional2013-06-30Completed
Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy [NCT03590080]32 participants (Actual)Observational2011-01-01Completed
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study [NCT03437746]Phase 278 participants (Actual)Interventional2018-03-01Terminated(stopped due to insufficient rate of inclusion)
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness [NCT05929755]Phase 480 participants (Anticipated)Interventional2023-05-12Recruiting
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial [NCT05927233]Phase 460 participants (Anticipated)Interventional2023-04-01Recruiting
The D3 Study: Drug Delivery vs Drops - A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% in Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery [NCT04273282]Phase 431 participants (Actual)Interventional2019-12-16Completed
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710]30 participants (Actual)Interventional2011-03-31Completed
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee [NCT01209364]Phase 3442 participants (Actual)Interventional2007-03-31Completed
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial. [NCT03249844]Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to discontinuation of the trial)
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692]Phase 216 participants (Actual)Interventional2000-08-31Completed
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics in Kidney Transplant Recipients [NCT06044558]507 participants (Actual)Observational2022-09-01Completed
[NCT00733096]Phase 2/Phase 384 participants (Actual)Interventional2008-08-31Completed
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial [NCT01274260]Phase 2100 participants (Anticipated)Interventional2010-10-31Active, not recruiting
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation [NCT00807586]Phase 4119 participants (Actual)Interventional2008-12-31Completed
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157]Phase 3680 participants (Anticipated)Interventional2024-01-22Not yet recruiting
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) [NCT04408625]Phase 1/Phase 223 participants (Anticipated)Interventional2020-11-09Recruiting
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study [NCT03511625]Phase 36 participants (Anticipated)Interventional2018-10-02Active, not recruiting
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145]Phase 242 participants (Anticipated)Interventional2020-08-31Recruiting
High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease [NCT05103397]Phase 475 participants (Anticipated)Interventional2021-10-16Recruiting
Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minim [NCT04563559]Phase 2/Phase 30 participants (Actual)Interventional2020-11-30Withdrawn(stopped due to PI decided not to open study)
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital [NCT04847687]300 participants (Actual)Observational2021-03-01Completed
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect [NCT04622917]Phase 444 participants (Actual)Interventional2019-04-10Active, not recruiting
Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow [NCT05062681]Phase 460 participants (Anticipated)Interventional2021-09-15Recruiting
Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar [NCT04816253]72 participants (Actual)Interventional2021-02-10Completed
[NCT03067753]Phase 228 participants (Anticipated)Interventional2016-12-31Recruiting
A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00002831]Phase 1/Phase 224 participants (Actual)Interventional1995-08-01Completed
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections [NCT04563299]Phase 410 participants (Actual)Interventional2020-12-09Terminated(stopped due to Subject Enrollment)
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO [NCT00493064]Phase 2/Phase 363 participants (Actual)Interventional2006-10-31Completed
A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile [NCT00555464]Phase 28 participants (Actual)Interventional2007-11-30Terminated(stopped due to The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas)
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT01579513]190 participants (Actual)Interventional2012-06-30Completed
A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas [NCT00624416]Phase 1/Phase 210 participants (Actual)Interventional2007-10-31Completed
A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis [NCT01369745]Phase 2294 participants (Actual)Interventional2011-06-30Completed
Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial [NCT03383328]Phase 4470 participants (Actual)Interventional2018-02-01Completed
Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome [NCT04515966]Phase 470 participants (Anticipated)Interventional2020-12-01Recruiting
Rituximab (RTX) Therapy in Steroid Resistant Patients or Patients Relapsing After Intravenous Steroids With Active TAO [NCT02378298]Phase 426 participants (Actual)Interventional2011-12-31Active, not recruiting
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial [NCT04873583]Phase 370 participants (Anticipated)Interventional2021-11-16Recruiting
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085]Phase 34,772 participants (Anticipated)Interventional2019-10-31Recruiting
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone [NCT02242630]61 participants (Actual)Interventional2014-09-30Completed
A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model [NCT01730872]Phase 416 participants (Actual)Interventional2012-11-30Completed
The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast [NCT02479074]Phase 449 participants (Actual)Interventional2016-01-31Completed
First Line Treatment of Familiar Lymphohistiocytosis by Alemtuzumab (CAMPATH®) [NCT02472054]Phase 1/Phase 229 participants (Actual)Interventional2015-06-29Completed
Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy [NCT04391439]40 participants (Actual)Observational2011-01-01Completed
Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial [NCT03289338]Phase 2/Phase 336 participants (Actual)Interventional2016-06-01Completed
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients [NCT03110822]Phase 1134 participants (Anticipated)Interventional2017-02-01Recruiting
Effectiveness and Safety of Efgartigimod in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Controlled, Retrospective, Real-Word Study [NCT06118398]24 participants (Anticipated)Observational2023-11-05Not yet recruiting
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study [NCT04192656]Phase 4102 participants (Anticipated)Interventional2019-11-01Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty [NCT02319343]Phase 370 participants (Actual)Interventional2015-01-31Completed
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy [NCT05177939]Phase 340 participants (Anticipated)Interventional2022-03-03Recruiting
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]Phase 4878 participants (Anticipated)Interventional2023-05-01Recruiting
Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy [NCT04876534]Phase 264 participants (Anticipated)Interventional2019-12-18Recruiting
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mi [NCT00833495]Phase 2155 participants (Actual)Interventional2009-01-31Completed
Parasitic Ulcer Treatment Trial Pilot [NCT03484507]Phase 249 participants (Actual)Interventional2018-01-01Active, not recruiting
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse [NCT04810156]Phase 260 participants (Anticipated)Interventional2021-04-07Recruiting
Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms [NCT02299115]Phase 30 participants (Actual)Interventional2017-09-05Withdrawn(stopped due to Most centres are now using oral steroids as 1st line treatment so question of efficacy is no longer of high interest.)
Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP) [NCT03636165]Phase 490 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium. [NCT02317601]Phase 4122 participants (Actual)Interventional2014-12-31Completed
Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial) [NCT04636671]Phase 3690 participants (Actual)Interventional2021-04-14Completed
Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial [NCT03393949]Phase 4112 participants (Actual)Interventional2015-07-01Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspe [NCT02517619]Phase 3251 participants (Actual)Interventional2016-01-16Completed
Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS) [NCT01624805]Phase 2100 participants (Anticipated)Interventional2012-06-25Recruiting
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients [NCT05220319]Phase 4672 participants (Anticipated)Interventional2022-02-03Recruiting
Comparison of Follow-up and Steroid Treatment Results in Intussusception in Children [NCT05640375]Phase 1/Phase 2120 participants (Anticipated)Interventional2019-12-24Recruiting
The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion [NCT03311425]Phase 3140 participants (Actual)Interventional2014-08-01Completed
Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development [NCT04832269]80 participants (Anticipated)Observational2020-10-19Recruiting
Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections [NCT06000709]Phase 440 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant [NCT04046549]Phase 225 participants (Actual)Interventional2019-10-30Completed
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00057811 (4) [back to overview]Toxic Death
NCT00066469 (1) [back to overview]Event-free Survival
NCT00097448 (1) [back to overview]Hearing Improvement
NCT00109928 (4) [back to overview]2-year Overall Survival Rate
NCT00109928 (4) [back to overview]2-year Progression-free Survival Rate
NCT00109928 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00109928 (4) [back to overview]Response Rate
NCT00128180 (10) [back to overview]Duration of ICU Stays
NCT00128180 (10) [back to overview]Duration of Hospital Stay in Days
NCT00128180 (10) [back to overview]Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry
NCT00128180 (10) [back to overview]Number of Participants With SAEs
NCT00128180 (10) [back to overview]The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation
NCT00128180 (10) [back to overview]Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry
NCT00128180 (10) [back to overview]Duration of Shock and/or Pressor/Inotropic Support
NCT00128180 (10) [back to overview]Length of Time on a Ventilator
NCT00128180 (10) [back to overview]Number of Participants Intubated and Placed on a Ventilator After Study Entry.
NCT00128180 (10) [back to overview]Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)
NCT00185692 (2) [back to overview]Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
NCT00185692 (2) [back to overview]Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
NCT00186628 (4) [back to overview]Incidence of Relapse
NCT00186628 (4) [back to overview]Chronic Graft-vs-Host Disease (cGvHD)
NCT00186628 (4) [back to overview]Overall Survival
NCT00186628 (4) [back to overview]Mortality
NCT00248534 (4) [back to overview]6-month Progression-free Survival
NCT00248534 (4) [back to overview]Number of Participants Alive at 3 Years
NCT00248534 (4) [back to overview]Percentage of Participants With Objective Response
NCT00248534 (4) [back to overview]1 Year Overall Survival Rate
NCT00257933 (1) [back to overview]Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
NCT00278564 (1) [back to overview]Survival
NCT00290589 (3) [back to overview]Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable
NCT00290589 (3) [back to overview]Functional Disability Scales
NCT00290589 (3) [back to overview]Number of Patients Using Analgesics
NCT00309907 (6) [back to overview]Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
NCT00309907 (6) [back to overview]Plasma Cytokine IL6 Level
NCT00309907 (6) [back to overview]C-reactive Protein Levels
NCT00309907 (6) [back to overview]Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
NCT00309907 (6) [back to overview]Survival Rate
NCT00309907 (6) [back to overview]Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 5 to Day 7
NCT00332696 (11) [back to overview]Participant's Quality of Life Using the Edmonton Scale
NCT00332696 (11) [back to overview]Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 10 to Day 13
NCT00332696 (11) [back to overview]Number of Participants With Relief From Obstruction at Day 7 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
NCT00345046 (1) [back to overview]Percent Change in Flare at Resolution
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Successful Natural Killer Cell Expansion
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 24 Months
NCT00354172 (15) [back to overview]Number of Patients Who Were Disease-free and Alive at 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Neutrophil Engraftment
NCT00354172 (15) [back to overview]Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Platelet Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died Due to Transplant.
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 12 Months
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
NCT00393367 (12) [back to overview]Change in Mean Heart Rate
NCT00393367 (12) [back to overview]Median Change in Asthma Score 2 Hours After Intervention
NCT00393367 (12) [back to overview]Mean Change in Asthma Score at 2 Hours
NCT00393367 (12) [back to overview]Serious Adverse Events
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
NCT00393367 (12) [back to overview]Number of Participants With Adverse Events (Non-serious).
NCT00393367 (12) [back to overview]Relapse / Readmission Numbers.
NCT00393367 (12) [back to overview]Oxygen Saturation.
NCT00393367 (12) [back to overview]Number of Subjects Remaining in the Severe Asthma Category
NCT00393367 (12) [back to overview]Mean Change in Respiratory Rate.
NCT00393367 (12) [back to overview]Number of Patients Hospitalized
NCT00423098 (10) [back to overview]Number of Patients With Treatment Failure
NCT00423098 (10) [back to overview]Duration of Exposure to Study Medication
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00423098 (10) [back to overview]Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
NCT00423098 (10) [back to overview]Number of Patients With Adverse Events and Infections
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Moderate to Severe Flares
NCT00423098 (10) [back to overview]Number of Patients With Partial Remission
NCT00424489 (1) [back to overview]Survival
NCT00443430 (3) [back to overview]Clinical Remission on Medication
NCT00443430 (3) [back to overview]Proportion of Participants Who Attain Inactive Disease by 6 Months
NCT00443430 (3) [back to overview]Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
NCT00481832 (10) [back to overview]Relapse Rate
NCT00481832 (10) [back to overview]Overall Survival (OS)
NCT00481832 (10) [back to overview]Overall Mortality Rate
NCT00481832 (10) [back to overview]Median Time to Platelet Engraftment
NCT00481832 (10) [back to overview]Median Time to Neutrophile Engraftment
NCT00481832 (10) [back to overview]Incidence of Chronic Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Event-free Survival (EFS)
NCT00481832 (10) [back to overview]Incidence of Acute Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Achieving Full Donor Chimerism
NCT00481832 (10) [back to overview]Incidence of Chemotherapy-associated Pneumonitis
NCT00492973 (5) [back to overview]Amount of Pain Medication Taken Per Day
NCT00492973 (5) [back to overview]Length of Hospital Stay
NCT00492973 (5) [back to overview]Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
NCT00492973 (5) [back to overview]Knee Society Scores
NCT00492973 (5) [back to overview]Knee Range of Motion
NCT00493064 (1) [back to overview]Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
NCT00521989 (1) [back to overview]Change From Baseline to Day 98 Using the WOMAC Pain Question #1
NCT00551707 (2) [back to overview]Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
NCT00551707 (2) [back to overview]Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
NCT00553202 (2) [back to overview]Cumulative Incidence of NK Cell Reconstitution
NCT00553202 (2) [back to overview]Overall Survival (OS)
NCT00555464 (2) [back to overview]Response of Hemangioma (IH) to Treatment
NCT00555464 (2) [back to overview]Toxicity to Medications
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00568633 (8) [back to overview]Transplant-related Mortality
NCT00568633 (8) [back to overview]Early Graft Loss
NCT00568633 (8) [back to overview]Disease-free Survival (DFS)
NCT00568633 (8) [back to overview]Overall Survival (OS)
NCT00568633 (8) [back to overview]Relapse Rate
NCT00568633 (8) [back to overview]Patients Completing the Intended Therapy in Both Arms
NCT00568633 (8) [back to overview]Complete Donor Hematopoietic Cell Chimerism
NCT00568633 (8) [back to overview]Non-relapse Mortality
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00595335 (8) [back to overview]Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
NCT00595335 (8) [back to overview]Failure Rate
NCT00595335 (8) [back to overview]Change in Proptosis
NCT00595335 (8) [back to overview]Change in Lid Fissure
NCT00595335 (8) [back to overview]Failure Rate at One Year
NCT00595335 (8) [back to overview]Change in Clinical Activity Score (CAS)
NCT00595335 (8) [back to overview]Change in Extraocular Motility
NCT00595335 (8) [back to overview]Change in Disease Severity
NCT00609609 (3) [back to overview]Non-relapse Mortality (NRM) at 6 Months
NCT00609609 (3) [back to overview]Day 56 Treatment Success
NCT00609609 (3) [back to overview]Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56
NCT00624416 (3) [back to overview]The Average Percent Volume Reduction in the Lipoma.
NCT00624416 (3) [back to overview]The Number of Subjects Elected to Have the Lipoma Removed.
NCT00624416 (3) [back to overview]The Number of Lipoma Increased in Volume.
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
NCT00634933 (12) [back to overview]Number of Tender Joints
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
NCT00634933 (12) [back to overview]Number of Swollen Joints
NCT00634933 (12) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI)
NCT00634933 (12) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
NCT00634933 (12) [back to overview]Disease Activity Score Based on 28-joints Count (DAS28)
NCT00634933 (12) [back to overview]Physician Global Assessment (PGA) of Disease Activity
NCT00634933 (12) [back to overview]Visual Analogue Scale for Pain (VAS-pain)
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
NCT00634933 (12) [back to overview]Patient Global Assessment (PtGA) of Disease Activity
NCT00671658 (1) [back to overview]Number of Participants With a Response
NCT00682357 (4) [back to overview]Change in Serum Osteocalcin
NCT00682357 (4) [back to overview]Change in Serum Cortisol
NCT00682357 (4) [back to overview]Change in Testosterone
NCT00682357 (4) [back to overview]Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
NCT00689078 (10) [back to overview]Ocular Redness at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 7
NCT00689078 (10) [back to overview]Ocular Redness at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 27
NCT00689078 (10) [back to overview]Ocular Redness at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 7
NCT00689078 (10) [back to overview]Ocular Itching at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 27
NCT00689078 (10) [back to overview]Ocular Itching at Baseline (Day 0)
NCT00699803 (1) [back to overview]Mean Aqueous Humor Prednisolone Acetate Concentration
NCT00720109 (5) [back to overview]Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00720109 (5) [back to overview]Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00732498 (4) [back to overview]Overall Response Rate
NCT00732498 (4) [back to overview]Complete Response Rate
NCT00732498 (4) [back to overview]Median Time to Progression
NCT00732498 (4) [back to overview]Progression-free Survival at 1 Year
NCT00733096 (4) [back to overview]Numerical Rating Leg Pain Score
NCT00733096 (4) [back to overview]Global Perceived Effect
NCT00733096 (4) [back to overview]Medication Reduction
NCT00733096 (4) [back to overview]Oswestry Disability Score
NCT00782717 (2) [back to overview]Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
NCT00782717 (2) [back to overview]Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
NCT00787722 (6) [back to overview]Quality of Life (QOL) Short Form - 36 (SF-36)
NCT00787722 (6) [back to overview]Disability Score: Expanded Disability Status Scale (EDSS)
NCT00787722 (6) [back to overview]Survival
NCT00787722 (6) [back to overview]Post HSCT Immune -Modulating Medication and Relapse
NCT00787722 (6) [back to overview]NMO-IgG Aquaporin- 4 Autoantibody Titer
NCT00787722 (6) [back to overview]Number of Patients Who Require No Device Assistance for Ambulation
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00802529 (3) [back to overview]Vertigo Attacks
NCT00802529 (3) [back to overview]Change in Hearing
NCT00802529 (3) [back to overview]Change in Speech Discrimination
NCT00806598 (1) [back to overview]Overall Response
NCT00807586 (3) [back to overview]Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
NCT00807586 (3) [back to overview]Repeat Intervention
NCT00807586 (3) [back to overview]Cardiac Pain Assessment
NCT00854061 (1) [back to overview]Means Aqueous Humor Prednisolone Acetate Concentration
NCT00908583 (4) [back to overview]Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
NCT00908583 (4) [back to overview]Number of Living Donor Transplant Candidates That Are Transplanted
NCT00908583 (4) [back to overview]Acute Rejection Rate
NCT00908583 (4) [back to overview]Overall Safety of Bortezomib
NCT00915473 (4) [back to overview]Mean Number of Days With Acute Medication Use
NCT00915473 (4) [back to overview]Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
NCT00915473 (4) [back to overview]Mean Frequency of Days With a Migraine
NCT00915473 (4) [back to overview]Mean Number of Hours With Moderate or Severe Migraine
NCT00929695 (12) [back to overview]Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
NCT00929695 (12) [back to overview]Non-relapse Mortality
NCT00929695 (12) [back to overview]Overall Survival
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hyperglycemia
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hypertension
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Myopathy
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Quality of Life
NCT00929695 (12) [back to overview]Progression to Grade III-IV Acute GVHD
NCT00929695 (12) [back to overview]Recurrent or Progressive Malignancy
NCT00929695 (12) [back to overview]Secondary Therapy for Acute GVHD Beyond Prednisone
NCT00929695 (12) [back to overview]Chronic Extensive GVHD
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the First Follow-up Visit
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
NCT00934843 (5) [back to overview]Total Intake/Output of Fluid
NCT00934843 (5) [back to overview]Urine Output
NCT00934843 (5) [back to overview]Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery
NCT00934843 (5) [back to overview]Inotropic Score
NCT00934843 (5) [back to overview]Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.
NCT00947765 (8) [back to overview]Pain(at 6 Months): Nirschl Staging
NCT00947765 (8) [back to overview]Pain (at 1 Week): Visual Analogue Scale(0 to 10)
NCT00947765 (8) [back to overview]Pain(at 1 Week): Nirschl Staging (0 to 7)
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 6 Months): Visual Analogue Scale
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 2
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 4
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 7
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 6
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 5
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 3
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
NCT00968253 (3) [back to overview]Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
NCT00968253 (3) [back to overview]Overall Response Rate (OR) Where OR = CR + CRp + CRi
NCT00968253 (3) [back to overview]Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
NCT00987831 (2) [back to overview]Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).
NCT00987831 (2) [back to overview]Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline
NCT01000610 (4) [back to overview]Change in Bone Density (in Participants Untreated With Bisphosphonates)
NCT01000610 (4) [back to overview]Number of Participants Reporting Adverse Events (AEs)
NCT01000610 (4) [back to overview]Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
NCT01000610 (4) [back to overview]Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
NCT01085097 (2) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01085097 (2) [back to overview]Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Incidence of Acute Graft-versus-host Disease (GVHD)
NCT01093586 (14) [back to overview]Occurrence of Serious Infections
NCT01093586 (14) [back to overview]Incidence of Chronic GVHD
NCT01093586 (14) [back to overview]Hematologic Engraftment
NCT01105650 (4) [back to overview]Time to Disease Progression
NCT01105650 (4) [back to overview]Response Rate
NCT01105650 (4) [back to overview]Overall Survival
NCT01105650 (4) [back to overview]Number of Participants With Progressive Disease at One Year
NCT01114503 (8) [back to overview]Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)
NCT01114503 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
NCT01124045 (13) [back to overview]Global Assessment Score of Postoperative Inflammation by Visit
NCT01124045 (13) [back to overview]Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
NCT01144143 (5) [back to overview]Change in Levels of Serum IL-6
NCT01144143 (5) [back to overview]Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee
NCT01144143 (5) [back to overview]Change in Joint Effusions From Day 0 to Day 56 Target Knee
NCT01144143 (5) [back to overview]Change in Serum CRP Day 0 to Day 56
NCT01144143 (5) [back to overview]Change in Serum SAA Levels Day 0 to Day 56
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count of 0
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
NCT01201798 (10) [back to overview]Proportion of Subjects Who Discontinued Due to Lack of Efficacy
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade of 0
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade ≤1
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
NCT01211665 (3) [back to overview]Severity of AEs and SAEs
NCT01211665 (3) [back to overview]Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
NCT01211665 (3) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01219933 (33) [back to overview]DAS28-ESR During the Noninterventional Phase
NCT01219933 (33) [back to overview]HAQ-DI During the Interventional Phase
NCT01219933 (33) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median GC Dose Taken During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
NCT01219933 (33) [back to overview]SF-36 Subscale Scores During the Interventional Phase
NCT01219933 (33) [back to overview]Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase
NCT01219933 (33) [back to overview]SJC and TJC During the Interventional Phase
NCT01219933 (33) [back to overview]Type of GC Taken at the End of the Noninterventional Phase
NCT01219933 (33) [back to overview]VAS for Pain (VAS-Pain) During the Interventional Phase
NCT01219933 (33) [back to overview]VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase
NCT01219933 (33) [back to overview]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase
NCT01219933 (33) [back to overview]Median Dose of Tocilizumab During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median Time Interval Between V1 and V2
NCT01219933 (33) [back to overview]Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Participants With GC Switches During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Start the GC Reduction Phase at V3
NCT01219933 (33) [back to overview]Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
NCT01219933 (33) [back to overview]Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Time-Averaged GC Dose Changes During the Interventional Phase
NCT01219933 (33) [back to overview]CDAI Score During the Interventional Phase
NCT01219933 (33) [back to overview]Clinical Disease Activity Index (CDAI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Interventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Noninterventional Phase
NCT01238536 (4) [back to overview]Pain Numeric Rating Scale
NCT01238536 (4) [back to overview]Leg Pain NRS
NCT01238536 (4) [back to overview]Roland Morris
NCT01238536 (4) [back to overview]Roland Morris Disability Questionnaire (RDQ)
NCT01267201 (4) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01267201 (4) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
NCT01267201 (4) [back to overview]Plasma Decay Half-life (t1/2)
NCT01267201 (4) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01272635 (5) [back to overview]Urgent Care Visits, ED Visits and Hospitalizations
NCT01272635 (5) [back to overview]Progression to Clinically Significant Lower Respiratory Tract Symptoms
NCT01272635 (5) [back to overview]OCELOT: Pediatric Respiratory Assessment Measure
NCT01272635 (5) [back to overview]Drug Related Side Effects
NCT01272635 (5) [back to overview]Asthma Related Symptoms Among RTI Progressing to Severe LRTI
NCT01283009 (1) [back to overview]60-day Mortality
NCT01319981 (3) [back to overview]Complete Response Duration
NCT01319981 (3) [back to overview]Number of Patients With Complete Remission at One Year
NCT01319981 (3) [back to overview]Overall Survival
NCT01369745 (1) [back to overview]Change From Baseline in DAS28-CRP at 12 Weeks
NCT01381874 (7) [back to overview]Progression-Free Survival (PFS)
NCT01381874 (7) [back to overview]Overall Survival (OS)
NCT01381874 (7) [back to overview]Duration of Response
NCT01381874 (7) [back to overview]Clinical Benefit Rate
NCT01381874 (7) [back to overview]Overall Response Rate (ORR)
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
NCT01448213 (2) [back to overview]Number of Eyes With Intraocular Pressure (IOP) Elevation
NCT01448213 (2) [back to overview]Number of Eyes With Immunologic Graft Rejection Episodes
NCT01465334 (11) [back to overview]Number of Participants With Overall CR
NCT01465334 (11) [back to overview]Transplant Rate
NCT01465334 (11) [back to overview]Overall Objective Response Rate (ORR)
NCT01465334 (11) [back to overview]3-year Overall Survival (OS) Probability
NCT01465334 (11) [back to overview]3-Year Progression-Free Survival (PFS) Probability
NCT01465334 (11) [back to overview]Induction Overall Response Rate (ORR)
NCT01465334 (11) [back to overview]Number of Participants Achieving Induction Complete Response (CR)
NCT01465334 (11) [back to overview]Overall MRD Negative Rate
NCT01465334 (11) [back to overview]Number of Participants Completing Only 2 Cycles of Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants Completing Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction
NCT01475643 (2) [back to overview]Anterior Chamber Cells & Flare
NCT01475643 (2) [back to overview]Anterior Chamber Inflammation
NCT01496976 (4) [back to overview]Rate of Progression/Relapse Free Survival (PFS)
NCT01496976 (4) [back to overview]Number of Participants With Partial Response (PR)
NCT01496976 (4) [back to overview]Number of Participants With Overall Survival (OS)
NCT01496976 (4) [back to overview]Number of Participants With Complete Response (CR)
NCT01497496 (1) [back to overview]Objective Response Rate (ORR)
NCT01534195 (4) [back to overview]Conjunctival Redness Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Ocular Itching Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Episcleral Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Ciliary Redness Change From Baseline to Day 6
NCT01559675 (1) [back to overview]Orthostatic Hypotension
NCT01579513 (5) [back to overview]Duration of Mechanical Ventilation Post Cardiac Surgery.
NCT01579513 (5) [back to overview]Intensive Care Unit Stay
NCT01579513 (5) [back to overview]Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
NCT01579513 (5) [back to overview]Neurodevelopmental Outcome
NCT01579513 (5) [back to overview]Hospital Stay
NCT01652495 (3) [back to overview]Reduction of Pain Severity Expressed as Percentage Change in VAS Score
NCT01652495 (3) [back to overview]Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
NCT01652495 (3) [back to overview]Functional Improvement Measured According to Percentage Change in Constant Score
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
NCT01724021 (14) [back to overview]Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
NCT01724021 (14) [back to overview]Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
NCT01724021 (14) [back to overview]Progression-free Survival (PFS)
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
NCT01724021 (14) [back to overview]Overall Survival (OS)
NCT01724021 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01724021 (14) [back to overview]Event-free Survival (EFS)
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
NCT01724021 (14) [back to overview]Disease-free Survival (DFS)
NCT01724021 (14) [back to overview]Complete Response (CR) Rate
NCT01724021 (14) [back to overview]Summary of Observed Serum Rituximab Concentration
NCT01724021 (14) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Score
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Rituximab Antibodies Over Time
NCT01730872 (3) [back to overview]Inflammation Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Ocular Redness Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Ocular Itching Change From Baseline to Day 6
NCT01783847 (2) [back to overview]Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4
NCT01783847 (2) [back to overview]Number of Participants With Change/Improvement Visual Acuity From the Beseline
NCT01809132 (4) [back to overview]MELD Score at 28 Days
NCT01809132 (4) [back to overview]MELD Score at 90 Days
NCT01809132 (4) [back to overview]MELD Score at 180 Days
NCT01809132 (4) [back to overview]180 Days Mortality
NCT01853072 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01853072 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01853072 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01853072 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01853696 (2) [back to overview]Immunologic Graft Rejection Episode
NCT01853696 (2) [back to overview]Intraocular Pressure
NCT01872611 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01872611 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01875237 (8) [back to overview]To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
NCT01875237 (8) [back to overview]To Assess the Proportions of GvHD Response Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
NCT01875237 (8) [back to overview]To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
NCT01875237 (8) [back to overview]To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
NCT01875237 (8) [back to overview]Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
NCT01977781 (7) [back to overview]Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
NCT01977781 (7) [back to overview]Visual Acuity
NCT01977781 (7) [back to overview]Tear Film Break-Up Time
NCT01977781 (7) [back to overview]Schirmer Tear Test (mm)
NCT01977781 (7) [back to overview]Ocular Surface Disease Index (OSDI) Questionnaire
NCT01977781 (7) [back to overview]Intraocular Pressure
NCT01977781 (7) [back to overview]Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)
NCT02006706 (2) [back to overview]Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT02006706 (2) [back to overview]Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
NCT02038452 (44) [back to overview]QALYS at 6 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 24 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 12 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months (CC)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 24 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (CC)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
NCT02038452 (44) [back to overview]Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT02167217 (1) [back to overview]Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)
NCT02176031 (6) [back to overview]GVHD-free Survival Rate
NCT02176031 (6) [back to overview]Rate of GVHD Flares
NCT02176031 (6) [back to overview]GI aGVHD Response Rate
NCT02176031 (6) [back to overview]Graft-verus-host Disease (GVHD) Response Rate
NCT02176031 (6) [back to overview]Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.
NCT02176031 (6) [back to overview]Overall Survival (OS) Rate
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Mortality (TRM)
NCT02199041 (9) [back to overview]Number of Participants With Secondary Graft Failure
NCT02199041 (9) [back to overview]Number of Participants With Overall Survival (OS)
NCT02199041 (9) [back to overview]Number of Participants With Neutrophil Engraftment
NCT02199041 (9) [back to overview]Number of Participants With Event-free Survival (EFS)
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Morbidity
NCT02199041 (9) [back to overview]Number of Participants With Malignant Relapse
NCT02199041 (9) [back to overview]Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02256969 (4) [back to overview]Tear Break Up Time (TBUT)
NCT02256969 (4) [back to overview]Ocular Surface Disease Index (OSDI)
NCT02256969 (4) [back to overview]Symptom Assessment in Dry Eye (SANDE)
NCT02256969 (4) [back to overview]Corneal Fluorescein Staining (CFS)
NCT02260934 (15) [back to overview]Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Participant, By Week 96
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Event by Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 48
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02296346 (1) [back to overview]Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
NCT02406209 (1) [back to overview]Anterior Chamber Cell Grade at Week 8
NCT02464657 (4) [back to overview]Relapse Free Survival
NCT02464657 (4) [back to overview]Event-Free Survival (EFS)
NCT02464657 (4) [back to overview]Maximum Tolerated Dose (MTD) of Nivolumab
NCT02464657 (4) [back to overview]Overall Survival
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fear Swallow)
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Duration)
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Neck Pain
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Liquid
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Solid
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Food Selection)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Mental)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Sleep)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Burden)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Social)
NCT02539394 (19) [back to overview]Patient Reported Swallowing Difficulty Over 1 Year
NCT02539394 (19) [back to overview]Patients' Neck Disability
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Desire)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Communication)
NCT02539394 (19) [back to overview]Adverse Event
NCT02539394 (19) [back to overview]Fusion Rate
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fatigue)
NCT02569437 (5) [back to overview]Subjective Symptom Composite Scoring
NCT02569437 (5) [back to overview]Visual Analog Scale
NCT02569437 (5) [back to overview]Endoscopic Nasal Polyp Score
NCT02569437 (5) [back to overview]Middle Meatus Culture
NCT02569437 (5) [back to overview]Sino-nasal Outcome Test (SNOT 22)
NCT02576249 (3) [back to overview]Pain Scale Score
NCT02576249 (3) [back to overview]Tegner Activity Level Scale
NCT02576249 (3) [back to overview]The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
NCT02652390 (6) [back to overview]Palmar Pain Score
NCT02652390 (6) [back to overview]Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
NCT02652390 (6) [back to overview]Bodily Pain Score
NCT02652390 (6) [back to overview]11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
NCT02652390 (6) [back to overview]Symptom Severity Score
NCT02652390 (6) [back to overview]Satisfaction Score
NCT02790788 (22) [back to overview]Core Body Temperature in Degrees Celcius.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Organ Failure-free Days.
NCT02790788 (22) [back to overview]Survival to Hospital Discharge With Favorable Functional Outcome.
NCT02790788 (22) [back to overview]Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.
NCT02790788 (22) [back to overview]Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.
NCT02790788 (22) [back to overview]Left and Right Ventricular Ejection Fraction (%) by Echocardiography.
NCT02790788 (22) [back to overview]Steroid-associated Complications.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Eccentricity Index by Echocardiography.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02798523 (1) [back to overview]Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
NCT02828358 (5) [back to overview]Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
NCT02847494 (3) [back to overview]Number of Participants With Sustained Headache Freedom
NCT02847494 (3) [back to overview]Headache Days as Self-reported by Participants
NCT02847494 (3) [back to overview]Medication Preference as Assessed by Self-report
NCT02953678 (10) [back to overview]Nonrelapse Mortality (NRM)
NCT02953678 (10) [back to overview]Relapse-related Mortality Rate
NCT02953678 (10) [back to overview]Relapse Rate
NCT02953678 (10) [back to overview]Percentage of Participants With Three-month DOR
NCT02953678 (10) [back to overview]Percentage of Participants With Six-month Duration of Response (DOR)
NCT02953678 (10) [back to overview]Overall Survival (OS)
NCT02953678 (10) [back to overview]Failure-free Survival (FFS)
NCT02953678 (10) [back to overview]Overall Response Rate (ORR) at Day 28
NCT02953678 (10) [back to overview]Overall Response Rate (ORR)
NCT02953678 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Incidence of Chronic Graft-versus-host Disease (GvHD)
NCT02956122 (22) [back to overview]Infection-related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
NCT02956122 (22) [back to overview]Overall Survival (OS) - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Transplant-related Mortality
NCT02956122 (22) [back to overview]Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
NCT02956122 (22) [back to overview]Failure-free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]All-cause Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Systemic Clearance at Steady State (CLss) of GLASSIA
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response at Day 56
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response (OR) At Day 28
NCT02956122 (22) [back to overview]"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"
NCT02956122 (22) [back to overview]Apparent Terminal Half-life (t1/2) of GLASSIA
NCT02956122 (22) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
NCT02956122 (22) [back to overview]Number of Participants With Recurrence of Primary Malignancies
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
NCT02956122 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of GLASSIA
NCT02956122 (22) [back to overview]Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
NCT02962284 (6) [back to overview]Number of Subjects With Adverse Events
NCT02962284 (6) [back to overview]Percentage of Subjects With Prostate Specific Antigen - 50 Response
NCT02962284 (6) [back to overview]Proportion of Subjects With Disease Progression
NCT02962284 (6) [back to overview]Prostate Specific Antigen Levels
NCT02962284 (6) [back to overview]Testosterone Complete Suppression
NCT02962284 (6) [back to overview]Testosterone Levels
NCT03123614 (4) [back to overview]Uncorrected Visual Acuity
NCT03123614 (4) [back to overview]Number of Eyes With Corneal Haze
NCT03123614 (4) [back to overview]Change in Intraocular Pressure (IOP) From Baseline Through Month 3
NCT03123614 (4) [back to overview]Best Corrected Visual Acuity at 3 Months
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Immunosuppressive Medications
NCT03139604 (20) [back to overview]Cmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]AUC of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]CL/F of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Cmin of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Duration of Response
NCT03139604 (20) [back to overview]Failure-free Survival
NCT03139604 (20) [back to overview]Incidence Rate of aGVHD Flares
NCT03139604 (20) [back to overview]Incidence Rate of Secondary Graft Failure
NCT03139604 (20) [back to overview]Malignancy Relapse-related Mortality Rate
NCT03139604 (20) [back to overview]Number of Treatment-emergent Adverse Events With INCB39110
NCT03139604 (20) [back to overview]Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
NCT03139604 (20) [back to overview]Overall Survival (OS)
NCT03139604 (20) [back to overview]Relapse Rate of Malignant and Nonmalignant Hematologic Disease
NCT03139604 (20) [back to overview]Time to Response
NCT03139604 (20) [back to overview]Tmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Incidence Rate of cGVHD
NCT03139604 (20) [back to overview]Nonrelapse Mortality
NCT03139604 (20) [back to overview]Objective Response Rate
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Corticosteroids
NCT03229538 (7) [back to overview]Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
NCT03229538 (7) [back to overview]Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories
NCT03229538 (7) [back to overview]Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.
NCT03229538 (7) [back to overview]Number of Participants With a Post-operative Length of Stay Greater Than 90 Days
NCT03229538 (7) [back to overview]Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)
NCT03229538 (7) [back to overview]Number of Participants With Post-operative Low Cardiac Output Syndrome
NCT03229538 (7) [back to overview]Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
NCT03232749 (3) [back to overview]Visual Analog Scale Scores at Each Time Point.
NCT03232749 (3) [back to overview]ASES Scores at Each Time Point
NCT03232749 (3) [back to overview]SST (Simple Shoulder Test) Scores at Each Time Point
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03403517 (5) [back to overview]Total Complication Rate
NCT03403517 (5) [back to overview]Mortality
NCT03403517 (5) [back to overview]Hospital Stay
NCT03403517 (5) [back to overview]Complications, Post-anesthesia Care Unit (PACU)
NCT03403517 (5) [back to overview]PACU Stay
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT03593902 (2) [back to overview]Survival of Treatment
NCT03593902 (2) [back to overview]Change in Skin Score by mRSS
NCT03704584 (3) [back to overview]Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
NCT03704584 (3) [back to overview]10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
NCT03704584 (3) [back to overview]Number of Patients With Subsequent Reinjection and Surgical Operation
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03818737 (6) [back to overview]Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score
NCT03818737 (6) [back to overview]Change in Visual Analog Pain Scale (VAS-pain) Score
NCT03818737 (6) [back to overview]Change in EuroQuality of Life (EQ-5D-3L) Index Score
NCT03818737 (6) [back to overview]Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score
NCT03818737 (6) [back to overview]Overall MRI Grade of Osteoarthritis
NCT03818737 (6) [back to overview]Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
NCT03852537 (14) [back to overview]Oxygen-free Days
NCT03852537 (14) [back to overview]Cardiovascular Dysfunction
NCT03852537 (14) [back to overview]Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing
NCT03852537 (14) [back to overview]Organ Failure
NCT03852537 (14) [back to overview]ICU Admission
NCT03852537 (14) [back to overview]Mortality
NCT03852537 (14) [back to overview]Myocardial Injury
NCT03852537 (14) [back to overview]Need for High Flow Nasal Cannula Oxygen
NCT03852537 (14) [back to overview]Need for Invasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Need for Noninvasive Mechanical Ventilation
NCT03852537 (14) [back to overview]New Onset Cardiac Arrhythmias
NCT03852537 (14) [back to overview]Occurrence of Delirium
NCT03852537 (14) [back to overview]Occurrence of Hyperglycemia
NCT03852537 (14) [back to overview]Occurrence of Secondary Infection
NCT04046549 (7) [back to overview]Percentage of Participants With Antibody-Mediated Rejection
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Acute Rejections
NCT04046549 (7) [back to overview]Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48
NCT04184999 (1) [back to overview]Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
NCT04233164 (1) [back to overview]Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT04323592 (6) [back to overview]Admission to Intensive Care Unit (ICU)
NCT04323592 (6) [back to overview]Change in C-reactive Protein (CRP)
NCT04323592 (6) [back to overview]Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
NCT04323592 (6) [back to overview]Endotracheal Intubation (Invasive Mechanical Ventilation)
NCT04323592 (6) [back to overview]Number of Days Free From Mechanical Ventilation
NCT04323592 (6) [back to overview]In-hospital Death Within 28 Days
NCT04380857 (5) [back to overview]Loss of Lines in Uncorrected Visual Acuity
NCT04380857 (5) [back to overview]Mean Change in Pain
NCT04380857 (5) [back to overview]Patient Preference Between Groups
NCT04380857 (5) [back to overview]Number of Lines Lost From Best Corrected Visual Acuity
NCT04380857 (5) [back to overview]Post op Pain Management Per Eye
NCT04900220 (2) [back to overview]Incidence of Pain
NCT04900220 (2) [back to overview]Intensity of Pain
NCT05113901 (18) [back to overview]Number of Participants With Complications Following Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Range of Motion in Degrees at Pre and Post Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05438277 (1) [back to overview]Incidence of a Flare Reaction

Response Rate

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years

Interventionpercentage of participants analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88
Group C (Chemotherapy, Monoclonal Antibody Therapy)83

[back to top]

Grade ≥ 3 Stomatitis

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Incidence of grade ≥ 3 stomatitisNo incidence of grade ≥ 3 stomatitis
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)441
Group C (Chemotherapy, Monoclonal Antibody Therapy)634

[back to top]

Minimal Residual Disease

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided

Interventionpercentage of samples analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)22
Group C (Chemotherapy, Monoclonal Antibody Therapy)70

[back to top]

Toxic Death

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Toxic deathNo toxic death
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)045
Group C (Chemotherapy, Monoclonal Antibody Therapy)238

[back to top]

Event-free Survival

Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Cyclophosphamide, Prednisone, Rituximab71

[back to top]

Hearing Improvement

Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. (NCT00097448)
Timeframe: 2 months

InterventiondB (Mean)
Oral Steroids30.7
IT Steroids28.7

[back to top]

2-year Overall Survival Rate

The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS31

[back to top]

2-year Progression-free Survival Rate

Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS12

[back to top] [back to top]

Response Rate

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00109928)
Timeframe: up to 3 years or time of disease progression

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseNo Response
PEGS62520

[back to top]

Duration of ICU Stays

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active4.48
Placebo5.83

[back to top]

Duration of Hospital Stay in Days

Days (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active8.90
Placebo10.67

[back to top]

Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry

(NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active1
Placebo6

[back to top]

Number of Participants With SAEs

The Number of participants with SAEs (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active14
Placebo25

[back to top]

The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation

(NCT00128180)
Timeframe: 28 days

Interventionproportion of paticipants (Number)
Active0.27
Placebo0.47

[back to top]

Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry

Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active4
Placebo6

[back to top]

Duration of Shock and/or Pressor/Inotropic Support

Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.67
Placebo3.75

[back to top]

Length of Time on a Ventilator

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.64
Placebo4.95

[back to top]

Number of Participants Intubated and Placed on a Ventilator After Study Entry.

Participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active6
Placebo10

[back to top]

Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)

number of participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active0
Placebo0

[back to top]

Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning

number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells4

[back to top]

Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant

GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells1

[back to top]

Incidence of Relapse

Subjects who Relapsed following after Allogeneic HSCT (NCT00186628)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Prophylactic Rituximab18

[back to top]

Chronic Graft-vs-Host Disease (cGvHD)

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) (NCT00186628)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Prophylactic Rituximab20

[back to top]

Overall Survival

(NCT00186628)
Timeframe: 4 years

InterventionPercentage of participants by disease (Number)
Prophylactic Rituximab (CLL Patients)73
Prophylactic Rituximab (MCL Patients)69

[back to top]

Mortality

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. (NCT00186628)
Timeframe: Day 100 and 1 year

InterventionParticipants (Number)
Mortality within 100 days, all causesNonrelapse mortality within 1 yearRelapse + mortality within 1 year
Prophylactic Rituximab012

[back to top]

6-month Progression-free Survival

"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression" (NCT00248534)
Timeframe: 6 months

Interventionpercentage of participants (Number)
IV Rituximab13

[back to top]

Number of Participants Alive at 3 Years

The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead. (NCT00248534)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
IV Rituximab1

[back to top]

Percentage of Participants With Objective Response

Objective response rate of the combination of Rituximab and TMZ (NCT00248534)
Timeframe: 2 months

Interventionpercent of participants (Number)
IV Rituximab14

[back to top]

1 Year Overall Survival Rate

(NCT00248534)
Timeframe: 1 year

Interventionpercentage of participants (Number)
IV Rituximab71

[back to top]

Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered

(NCT00257933)
Timeframe: Median time from loading dose to home dose of albuterol

InterventionHours (Median)
High Dose Prednisolone35
Lower Dose Prednisolone33

[back to top]

Survival

Survival (NCT00278564)
Timeframe: up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation7

[back to top]

Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable

Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Intramuscular Methylprednisolone Acetate7.1
Placebo5.8

[back to top]

Functional Disability Scales

The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Median)
Intramuscular Methylprednisolone Acetate0
Placebo0

[back to top]

Number of Patients Using Analgesics

Use of analgesics for low back pain (within the previous 24 hours) (NCT00290589)
Timeframe: Assessed at 1 month

InterventionParticipants (Count of Participants)
Intramuscular Methylprednisolone Acetate8
Placebo17

[back to top]

Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy

Pulmonary response is defined as alive & come off of oxygen . (NCT00309907)
Timeframe: up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy74

[back to top]

Plasma Cytokine IL6 Level

Estimated mean and standard error of IL6 level (NCT00309907)
Timeframe: From baseline to days 7 and 28

Interventionpg/ml (Mean)
BaselineDay 7Day 28
Etanercept and Corticosteroid Therapy205.228.823.1

[back to top]

C-reactive Protein Levels

Estimated mean and standard deviation (NCT00309907)
Timeframe: From baseline to days 7, 14, 21, and 28

Interventionmg/dL (Mean)
BaselineDay 7 Non RespondersDay 7 RespondersDay 14 Non RespondersDay 14 RespondersDay 21 Non RespondersDay 21 RespondersDay 28 Non RespondersDay 28 Responders
Etanercept and Corticosteroid Therapy28.15.41.84.9110.71.619.65.3

[back to top]

Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0

Grade 3-5 organ toxicities attributable to etanercept. (NCT00309907)
Timeframe: Up to 56 days

InterventionPatients (Number)
Etanercept and Corticosteroid Therapy0

[back to top]

Survival Rate

Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS. (NCT00309907)
Timeframe: Up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy75

[back to top]

Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response. (NCT00309907)
Timeframe: At day 28

Interventionparticipants (Number)
With ResponseWithout Response
Etanercept and Corticosteroid Therapy208

[back to top]

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1. (NCT00332696)
Timeframe: Day 1

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide16178
Placebo13298

[back to top]

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14. (NCT00332696)
Timeframe: Day 14

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide22222
Placebo22311

[back to top]

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7. (NCT00332696)
Timeframe: Day 7

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide21253
Placebo15961

[back to top]

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: 1 Month

,
InterventionParticipants (Number)
Recurrence at Month 1No Recurrence at Month 1
Octreotide113
Placebo213

[back to top]

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 2

,
InterventionParticipants (Number)
Recurrence at Month 2No Recurrence at Month 2
Octreotide26
Placebo25

[back to top]

Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial). (NCT00332696)
Timeframe: Day 5 to Day 7

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day) since Day 5Vomiting episodes ≥2 (per day) since Day 5No Nasogastric Tube since Day 5Nasogastric Tube used since Day 5No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data
Octreotide222812272633
Placebo202522432525

[back to top]

Participant's Quality of Life Using the Edmonton Scale

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse. (NCT00332696)
Timeframe: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

,
InterventionScores on a scale (Mean)
Day 1 (n=30,29)Day 7 (n=24,26)Day 14 (n=20,14)Month 1 (n=11,13)Month 2 (n=7,4)Month 3 (n=2,2)
Octreotide4.124.234.304.183.460.05
Placebo4.123.373.854.493.231.60

[back to top]

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. (NCT00332696)
Timeframe: Day 1, Day 7 and Day 14

,
InterventionVomiting episodes (Mean)
Day 1Day 7 (n=31,31)Day 14 (n=28,27)
Octreotide1.20.30.3
Placebo0.60.40.5

[back to top]

Number of Participants With Treatment Success From Day 10 to Day 13

"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause." (NCT00332696)
Timeframe: Day 10 to Day 13

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day)Vomiting episodes ≥2 (per day)No Nasogastric Tube since Day 10Nasogastric Tube used since Day 10No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data, failure
Octreotide1219214718311
Placebo913213211417

[back to top]

Number of Participants With Relief From Obstruction at Day 7 and Day 14

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours. (NCT00332696)
Timeframe: Day 7 and Day 14

,
InterventionParticipants (Number)
Relief from Obstruction: Day 7No Relief from Obstruction: Day 7Relief from Obstruction: Day 14No Relief from Obstruction: Day 14
Octreotide9201110
Placebo1512105

[back to top]

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 3

,
InterventionParticipants (Number)
Recurrence at Month 3No Recurrence at Month 3
Octreotide03
Placebo02

[back to top]

Percent Change in Flare at Resolution

(NCT00345046)
Timeframe: 2 months

InterventionPercent change in flare (Mean)
Pred Forte 1%64.8
Econo Pred Plus 1%68.3
Predisolone Acetate 1%65.7

[back to top]

Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients1

[back to top]

Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients2

[back to top]

Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant

InterventionParticipants (Number)
Evaluable Patients6

[back to top]

Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant

InterventionParticipants (Number)
Evaluable Patients1

[back to top]

Number of Participants (Patients) With Chronic Graft-Versus-Host Disease

The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients1

[back to top]

Number of Participants (Patients) With Successful Natural Killer Cell Expansion

Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion

InterventionParticipants (Number)
Evaluable Patients3

[back to top]

Number of Participants (Patients) Who Experienced Relapse by 24 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant

InterventionParticipants (Number)
Evaluable Patients11

[back to top]

Number of Patients Who Were Disease-free and Alive at 24 Months

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients0

[back to top]

Number of Participants (Patients) Who Attained Neutrophil Engraftment

"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant

InterventionParticipants (Number)
Evaluable Patients13

[back to top]

Chimerism After Double Umbilical Cord Blood Transplant (UCBT)

Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months

InterventionPercentage of Engrafted Cells (Median)
Day 21Day 1006 Months
Evaluable Patients9210096.5

[back to top]

Number of Participants (Patients) Who Attained Platelet Engraftment

Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients5

[back to top]

Number of Participants (Patients) Who Died by 12 Months

Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant

InterventionParticipants (Number)
Evaluable Patients14

[back to top]

Number of Participants (Patients) Who Died by 24 Months

Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant

InterventionParticipants (Number)
Evaluable Patients15

[back to top]

Number of Participants (Patients) Who Died Due to Transplant.

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients4

[back to top]

Number of Participants (Patients) Who Experienced Relapse by 12 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients10

[back to top]

Number of Subjects Moving From the Severe Asthma to Mild Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)8
Placebo (Normal Saline)10

[back to top]

Change in Mean Heart Rate

Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol (NCT00393367)
Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionBeats per minute (Mean)
Budesonide Inhalation Suspension (BIS)12
Placebo (Normal Saline)13

[back to top]

Median Change in Asthma Score 2 Hours After Intervention

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Median)
Budesonide Inhalation Suspension (BIS)-3
Placebo (Normal Saline)-3

[back to top]

Mean Change in Asthma Score at 2 Hours

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Mean)
Budesonide Inhalation Suspension (BIS)-2.9
Placebo (Normal Saline)-3.0

[back to top]

Serious Adverse Events

Serious Adverse Events (NCT00393367)
Timeframe: 0-5 days

,
Interventionparticipants (Number)
Return within 5 days with hosptial admissionIncreased level of care
Budesonide Inhalation Suspension (BIS)21
Placebo (Saline)20

[back to top]

Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)22
Placebo (Normal Saline)11

[back to top]

Number of Participants With Adverse Events (Non-serious).

(NCT00393367)
Timeframe: within 30 days of the ED visit

,
InterventionParticipants (Number)
RhinorrheaHeadacheDiarrheaSore throatCoughHyperglycemia
Budesonide Inhalation Suspension (BIS)653422
Placebo (Normal Saline)1197330

[back to top]

Relapse / Readmission Numbers.

Participants admitted to the hospital within 5 days of the ED visit (NCT00393367)
Timeframe: within 5 days of ED visit

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)2
Placebo (Normal Saline)2

[back to top]

Oxygen Saturation.

Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. (NCT00393367)
Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

InterventionPercent Hemoglobin Saturation (Mean)
Budesonide Inhalation Suspension (BIS)1.0
Placebo (Normal Saline)1.0

[back to top]

Number of Subjects Remaining in the Severe Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)4
Placebo (Normal Saline)4

[back to top]

Mean Change in Respiratory Rate.

Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. (NCT00393367)
Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

InterventionBreaths per minute (Mean)
Budesonide Inhalation Suspension (BIS)-6
Placebo (Normal Saline)-6

[back to top]

Number of Patients Hospitalized

The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. (NCT00393367)
Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)56
Placebo (Saline)55

[back to top]

Number of Patients With Treatment Failure

Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionparticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose25142217
Standard Dose23192121

[back to top]

Duration of Exposure to Study Medication

The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1. (NCT00423098)
Timeframe: 24 weeks

Interventiondays (Mean)
Standard Dose164.5
Low Dose157.7

[back to top]

Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)

BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from baseline Week 4: (N= 40, 37)Change from baseline Week 12: (N= 41, 35)Change from baseline Week 24: (N= 40, 34)
Low Dose-5.5-8.7-9.4
Standard Dose-4.8-8.6-8.6

[back to top]

Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from Baseline to Week 4: (N= 39, 37)Change from Baseline to Week 12: (N= 41, 35)Change from Baseline to Week 24: (N= 39, 34)
Low Dose-7.7-10.3-9.8
Standard Dose-7.4-9.7-10.3

[back to top]

Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)

Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionmg/kg (Mean)
Week 12Week 24
Low Dose68.273.0
Standard Dose106.1114.2

[back to top]

Number of Patients With Adverse Events and Infections

Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. (NCT00423098)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
At least one adverse eventAny severe adverse eventAny drug related adverse eventAny serious adverse eventAny infectionAny severe infectionAny drug related infectionAny serious infection
Low Dose30316417161
Standard Dose357188253104

[back to top]

Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab. (NCT00423098)
Timeframe: 24 Weeks

,
InterventionParticipants (Number)
YesNo
Low Dose831
Standard Dose834

[back to top]

Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value. (NCT00423098)
Timeframe: 12 Weeks

,
Interventionparticipants (Number)
YesNo
Low Dose534
Standard Dose933

[back to top]

Number of Patients With Moderate to Severe Flares

A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72) (NCT00423098)
Timeframe: 12 and 24 weeks

,
Interventionparticipants (Number)
At week 12 - YesAt week 12 - NoAt week 24 - YesAt week 24 - No
Low Dose039039
Standard Dose042141

[back to top]

Number of Patients With Partial Remission

Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved. (NCT00423098)
Timeframe: Baseline to 12 and 24 weeks

,
InterventionParticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose11281425
Standard Dose16262022

[back to top]

Survival

Survival (NCT00424489)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation6

[back to top]

Clinical Remission on Medication

6 months of clinical inactive disease (NCT00443430)
Timeframe: 12 months or end of study

Interventionparticipants (Number)
Methotrexate Arm3
Methotrexate-Prednisolone-Etanercept Arm9

[back to top]

Proportion of Participants Who Attain Inactive Disease by 6 Months

(NCT00443430)
Timeframe: 6 months after initiation of study intervention

Interventionparticipants (Number)
Methotrexate Arm10
Methotrexate-Prednisolone-Etanercept Arm17

[back to top]

Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events

(NCT00443430)
Timeframe: Over 12 months maximum study participation per subject

Interventionevents (Number)
Methotrexate Arm1
Methotrexate-Prednisolone-Etanercept Arm2

[back to top]

Relapse Rate

Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT27

[back to top]

Overall Survival (OS)

Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT57

[back to top]

Overall Mortality Rate

Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT56

[back to top]

Median Time to Platelet Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant. (NCT00481832)
Timeframe: Up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT11

[back to top]

Median Time to Neutrophile Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant. (NCT00481832)
Timeframe: up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT17

[back to top]

Incidence of Chronic Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade at 6 months. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

[back to top]

Event-free Survival (EFS)

"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes." (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT35

[back to top]

Incidence of Acute Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade and at 6 months. (NCT00481832)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

[back to top]

Achieving Full Donor Chimerism

Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%. (NCT00481832)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT10

[back to top]

Incidence of Chemotherapy-associated Pneumonitis

Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT16

[back to top]

Amount of Pain Medication Taken Per Day

(NCT00492973)
Timeframe: Average of 3 days after surgery

Interventionmg/day morphine equivalant (Mean)
Control Group47.8
Corticosteroid46.0

[back to top]

Length of Hospital Stay

(NCT00492973)
Timeframe: days after surgery

Interventiondays (Mean)
Control Group3.5
Corticosteroid2.6

[back to top]

Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

(NCT00492973)
Timeframe: any point during the first postoperative year

InterventionNumber of participants with complication (Number)
Control Group0
Corticosteroid3

[back to top]

Knee Society Scores

The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion. (NCT00492973)
Timeframe: 3 months postoperative

Interventionunits on a scale (Mean)
Control Group87.1
Corticosteroid83.3

[back to top]

Knee Range of Motion

(NCT00492973)
Timeframe: 3 months

Interventiondegrees (Mean)
Control Group112.5
Corticosteroid112.4

[back to top]

Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.

improvement with combination of niacin and topical prednisolone acetate (NCT00493064)
Timeframe: one year

InterventionParticipants (Count of Participants)
Prospective Active Treatment63

[back to top]

Change From Baseline to Day 98 Using the WOMAC Pain Question #1

"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome." (NCT00521989)
Timeframe: Baseline to Day 98

Interventionmillimeters (Mean)
CRx-102 (2.7/90 mg)-32.4
CRx-102 (2.7/180 mg)-33.2
CRx-102 (2.7/360 mg)-37.3
Prednisolone-40.4
Placebo-34.6

[back to top]

Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: baseline to day 98

Interventionpercentage of change from baseline (Median)
CRx-102 (2.7/180)-29.90
CRx-102 (2.7/360)-40.84
Prednisolone15.92
Dipyridamole-33.67
Placebo-27.64

[back to top]

Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: Day 98

Interventionmg/L (Median)
CRx-102 (2.7/180)12.85
CRx-102 (2.7/360)14.25
Prednisolone21.85
Dipyridamole16.60
Placebo2.68

[back to top]

Cumulative Incidence of NK Cell Reconstitution

Cumulative incidence of successful reconstitution to donor level is calculated. (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)48.1

[back to top]

Overall Survival (OS)

OS - Time from HSCT until death (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)45.9

[back to top]

Response of Hemangioma (IH) to Treatment

"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume." (NCT00555464)
Timeframe: 6 weeks

,
Interventionparticipants (Number)
Progressive DiseasePartial ResponseComplete ResponseStable Disease
Oral Steroid Treatment Group1002
Vincristine Treatment Group0202

[back to top]

Toxicity to Medications

"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details." (NCT00555464)
Timeframe: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy

,
Interventionparticipants (Number)
Patients with Serious Adverse EventsPatients with Other Adverse Events
Oral Steroid Treatment Group00
Vincristine Treatment Group03

[back to top] [back to top]

Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

[back to top]

Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

[back to top]

Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

[back to top]

Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

[back to top]

Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

[back to top]

Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

[back to top]

Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

[back to top]

Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.

Interventionpercent probability (Number)
Arm B (IR/HR MLL-R Chemotherapy)38.89
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82

[back to top]

Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

[back to top] [back to top]

Early Graft Loss

Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG4

[back to top]

Disease-free Survival (DFS)

Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG5
Best Standard Care9

[back to top]

Overall Survival (OS)

Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG9
Best Standard Care13

[back to top]

Relapse Rate

Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG20
Best Standard Care24

[back to top]

Patients Completing the Intended Therapy in Both Arms

The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG100
Best Standard Care81.8

[back to top]

Complete Donor Hematopoietic Cell Chimerism

Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG56

[back to top]

Non-relapse Mortality

Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG1
Best Standard Care2

[back to top]

Number of Participants With Progression Free Survival (10 Years) by Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

[back to top]

Number of Participants With Overall Survival (10 Years) by Treatment

Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

[back to top]

Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points. (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Baseline QoL physicalBaseline QoL mental6 months QoL physical6 months QoL mental12 months QoL physical12 months QoL mental
Placebo39.946.140.346.146.749.4
Rituximab53.244.345.952.851.856.1

[back to top]

Failure Rate

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: 6 months after first infusion, 12 months after first infusion

,
Interventionpercentage of participants (Number)
Failure rate at 6 monthsFailure rate at 12 months
Placebo7550
Rituximab6946

[back to top]

Change in Proptosis

Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm. (NCT00595335)
Timeframe: baseline, 12 months after first infusion

,
Interventionmm (Mean)
Proptosis right eyeProptosis left eye
Placebo0.800.0
Rituximab0.820.1

[back to top]

Change in Lid Fissure

"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm." (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionmm (Median)
Lid fissure right eyeLid fissure left eye
Placebo00.5
Rituximab00

[back to top]

Failure Rate at One Year

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: one year

Interventionpercentage of participants (Number)
Rituximab46
Placebo50

[back to top]

Change in Clinical Activity Score (CAS)

The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease. (NCT00595335)
Timeframe: baseline, 6 months after the first infusion

Interventionunits on a scale (Mean)
Rituximab-1.2
Placebo-1.5

[back to top]

Change in Extraocular Motility

"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)." (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Change baseline-6 monthsChange baseline-12 months
Placebo2.51.5
Rituximab32

[back to top]

Change in Disease Severity

Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) ). (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionparticipants (Number)
Improvement by 1 classImprovement by 2 classesDeteriorationNo change
Placebo8202
Rituximab6223

[back to top]

Non-relapse Mortality (NRM) at 6 Months

Percentage of participants at 6 months whose deaths were without relapse/recurrence. (NCT00609609)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Corticosteroids19.6
ECP + Corticosteroids20.0

[back to top]

Day 56 Treatment Success

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status. (NCT00609609)
Timeframe: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

,
Interventionpercentage of participants (Number)
Skin-onlyVisceral InvolvementTotal
Corticosteroids574353
ECP + Corticosteroids724765

[back to top]

Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56

Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56. (NCT00609609)
Timeframe: Up to day 56

,
Interventionpercentage of participants (Number)
Day 28 Steroid dose Day 56 steroid dose < 0.1mg/kg
Corticosteroids1030
ECP + Corticosteroids23.543

[back to top]

The Average Percent Volume Reduction in the Lipoma.

(NCT00624416)
Timeframe: Baseline and 4 weeks

InterventionPercent Volume reduction (cc^3) (Mean)
Prednisolone and Isoproteronol50

[back to top]

The Number of Subjects Elected to Have the Lipoma Removed.

(NCT00624416)
Timeframe: After four weeks up to one year.

Interventionparticipants (Number)
Prednisolone and Isoproteronol8

[back to top]

The Number of Lipoma Increased in Volume.

(NCT00624416)
Timeframe: After four weeks of treatment up to one year.

InterventionLipomas (Number)
Prednisolone and Isoproteronol9

[back to top]

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.631.131.131.141.947.343.2
TRU-015 Induction Dose26.034.242.549.361.664.467.1
TRU-015 Single Dose21.334.744.052.064.062.761.3

[back to top]

Number of Tender Joints

The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventiontender joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.013.611.911.711.09.49.09.4
TRU-015 Induction Dose17.713.011.610.19.68.47.67.6
TRU-015 Single Dose16.811.910.79.88.87.37.68.1

[back to top]

Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24

ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP). (NCT00634933)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo16.2
TRU-015 Single Dose29.3
TRU-015 Induction Dose27.4

[back to top]

Number of Swollen Joints

The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00634933)
Timeframe: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionswollen joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo12.29.57.87.07.66.16.06.2
TRU-015 Induction Dose13.910.29.07.77.15.95.15.0
TRU-015 Single Dose12.39.08.56.96.05.14.84.7

[back to top]

Health Assessment Questionnaire Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo1.81.51.41.51.51.41.41.4
TRU-015 Induction Dose1.61.31.31.21.11.11.01.0
TRU-015 Single Dose1.71.41.41.31.31.21.21.2

[back to top]

Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2: good responseWeek 2: moderate responseWeek 2: no responseWeek 4: good responseWeek 4: moderate responseWeek 4: no responseWeek 8: good responseWeek 8: moderate responseWeek 8: no responseWeek 12: good responseWeek 12: moderate responseWeek 12: no responseWeek 16: good responseWeek 16: moderate responseWeek 16: no responseWeek 20: good responseWeek 20: moderate responseWeek 20: no responseWeek 24: good responseWeek 24: moderate responseWeek 24: no response
Placebo1.433.864.95.439.255.48.144.647.39.539.251.418.940.540.517.637.844.614.944.640.5
TRU-015 Induction Dose2.739.757.58.245.246.612.353.434.216.452.131.520.556.223.326.054.819.230.150.719.2
TRU-015 Single Dose6.738.754.714.741.344.014.744.041.321.353.325.334.741.324.029.352.018.726.746.726.7

[back to top]

Disease Activity Score Based on 28-joints Count (DAS28)

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.15.45.25.15.04.74.74.7
TRU-015 Induction Dose6.15.35.04.74.64.34.14.0
TRU-015 Single Dose5.85.14.94.64.33.94.04.1

[back to top]

Physician Global Assessment (PGA) of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.85.55.05.04.84.64.44.3
TRU-015 Induction Dose6.65.24.94.44.33.63.63.6
TRU-015 Single Dose6.45.15.04.14.13.73.83.7

[back to top]

Visual Analogue Scale for Pain (VAS-pain)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionmm (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo65.453.053.656.454.351.151.149.2
TRU-015 Induction Dose61.649.649.047.044.840.839.143.9
TRU-015 Single Dose62.547.748.945.842.339.339.539.2

[back to top]

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo0.01.41.41.46.82.72.7
TRU-015 Induction Dose1.40.01.42.76.86.89.6
TRU-015 Single Dose1.31.32.72.78.06.79.3

[back to top]

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20
Placebo0.06.812.214.916.216.2
TRU-015 Induction Dose6.86.88.213.731.528.8
TRU-015 Single Dose8.08.010.716.030.728.0

[back to top]

Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo7.36.26.06.25.96.65.55.3
TRU-015 Induction Dose7.05.65.65.35.24.64.54.7
TRU-015 Single Dose6.95.65.45.24.84.44.54.6

[back to top]

Number of Participants With a Response

Response - Complete remission (CR): Normalization peripheral blood & bone marrow 5% or & platelet count >100x10^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count <100x10^9/L. CR with incomplete recovery (CRi): CR but platelet count <100x10^9/L or absolute neutrophil count < 1x10^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2). (NCT00671658)
Timeframe: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days

InterventionParticipants (Number)
Complete Response (CR)Complete Response without Platelet RecoveryPartial Response (PR)
HYPER-CVAD19834

[back to top]

Change in Serum Osteocalcin

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/mL (Mean)
Group 1 - Standard Dose-2.18
Group 2 - Low Dose-0.45
Group 3 - Placebo-1.10

[back to top]

Change in Serum Cortisol

Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionmcg/dL (Mean)
Group 1 - Standard Dose-1.16
Group 2 - Low Dose0.65
Group 3 - Placebo1.30

[back to top]

Change in Testosterone

Outcome represents the mean change in testosterone level from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/dL (Mean)
Group 1 - Standard Dose0.08

[back to top]

Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)

Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

InterventionU/L (Mean)
Group 1 - Standard Dose-0.153
Group 2 - Low Dose-0.295
Group 3 - Placebo-0.148

[back to top]

Ocular Redness at Day 28

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.691.691.69
Pred Forte1.581.811.5
Pred Mild1.962.111.86
Tears Naturale1.811.941.72

[back to top]

Ocular Redness at Day 7

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.591.591.47
Pred Forte2.081.831.72
Pred Mild1.531.691.78
Tears Naturale1.591.661.5

[back to top]

Ocular Redness at Day 6

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.842.132.03
Pred Forte21.972
Pred Mild2.222.412.31
Tears Naturale2.112.282.17

[back to top]

Ocular Itching at Day 28

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.0321.78
Pred Forte1.831.971.89
Pred Mild2.252.642.71
Tears Naturale1.751.781.56

[back to top]

Ocular Redness at Day 27

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.441.631.53
Pred Forte1.721.721.53
Pred Mild2.142.111.89
Tears Naturale1.561.721.72

[back to top]

Ocular Redness at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.862.112
Pred Forte2.112.332.22
Pred Mild2.112.312.28
Tears Naturale2.082.252.06

[back to top]

Ocular Itching at Day 7

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.092.031.88
Pred Forte2.112.111.97
Pred Mild2.282.692.75
Tears Naturale2.031.941.72

[back to top]

Ocular Itching at Day 6

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.062.412.31
Pred Forte2.172.442.17
Pred Mild2.192.592.72
Tears Naturale2.332.532.14

[back to top]

Ocular Itching at Day 27

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex1.752.092
Pred Forte2.142.172.03
Pred Mild2.432.642.64
Tears Naturale2.031.841.72

[back to top]

Ocular Itching at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.613.063.08
Pred Forte2.532.923.03
Pred Mild3.083.473.44
Tears Naturale2.52.752.83

[back to top]

Mean Aqueous Humor Prednisolone Acetate Concentration

(NCT00699803)
Timeframe: 4 hours

Interventionng/mL (Mean)
T-Pred102.5
Pred Forte127.5

[back to top]

Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)

An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Interventionpercentage of patients (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

[back to top]

Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)10.5
Standard-risk0
High-risk66.7

[back to top]

Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

InterventionPts with DLTs (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1

[back to top]

Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years

InterventionPercent probability (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

[back to top]

Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

[back to top]

Overall Response Rate

To evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata [12]. (NCT00732498)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab77.3

[back to top]

Complete Response Rate

To evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy (NCT00732498)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
ESHAP Followed by Zevalin and Rituximab10

[back to top]

Median Time to Progression

To evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 5 years

Interventionmonths (Median)
ESHAP Followed by Zevalin and Rituximab10

[back to top]

Progression-free Survival at 1 Year

To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab38

[back to top]

Numerical Rating Leg Pain Score

0-10 pain score. 0= no pain, 10= worst imaginable pain. (NCT00733096)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Steroid2.54
Etanercept3.56
Saline3.78

[back to top]

Global Perceived Effect

Satisfaction. Number of participants with positive perceived global satisfaction. (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid23
Etanercept15
Saline17

[back to top]

Medication Reduction

Number of people who reduced medications (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid17
Etanercept9
Saline14

[back to top]

Oswestry Disability Score

0-100%. 0= no disability, 100% is complete disability (NCT00733096)
Timeframe: 1 month

Interventionpercentage of disability out of 100% (Mean)
Steroid22.4
Etanercept40.26
Saline30.00

[back to top]

Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. (NCT00782717)
Timeframe: From Day 7 to Day 90 (or Early Exit)

InterventionPercentage of patients (Number)
NEVANAC6
Nepafenac Vehicle12

[back to top]

Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). (NCT00782717)
Timeframe: 3 Months

InterventionPercentage of patients (Number)
NEVANAC3
Nepafenac Vehicle17

[back to top]

Quality of Life (QOL) Short Form - 36 (SF-36)

SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best. (NCT00787722)
Timeframe: pre-transplant 12mo and 5 years

Interventionscore on a scale (Median)
Pretransplant1 Year Post Transplant5 Year Post Transplant
Hematopoietic Stem Cell Transplantation30.8352.6961.63

[back to top]

Disability Score: Expanded Disability Status Scale (EDSS)

"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability." (NCT00787722)
Timeframe: pretransplant 6 month, 5 year

Interventionscore on a scale (Mean)
Pretransplant Disability Score (EDSS)1 Year Post Transplant Disability Score (EDSS)5 Year Post Transplant Disability Score (EDSS)
Hematopoietic Stem Cell Transplantation4.42.83.3

[back to top]

Survival

survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
6 months survival1 year survival2 year survival3 year survival4 year survival5 year survival
Hematopoietic Stem Cell Transplantation131212111111

[back to top]

Post HSCT Immune -Modulating Medication and Relapse

Number of immune - modulating medication and relapse evaluated 5 year - after the transplant (NCT00787722)
Timeframe: Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant

InterventionParticipants (Count of Participants)
Pre HSCT - Immunosuppression/Relapse Rate6 Mos Post HSCT Immunosuppression/ Relapse Rate1 Year Post HSCT Immunosuppression/Relapse Rate2 Year Post HSCT Immunosuppression/Relapse Rate3 Year Post HSCT Immunosuppression/Relapse Rate4 Year Post HSCT Immunosuppression/Relapse Rate5 Year Post HSCT Immunosuppression Relapse Rate
Hematopoietic Stem Cell Transplantation (HSCT)12113011

[back to top]

NMO-IgG Aquaporin- 4 Autoantibody Titer

NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. (NCT00787722)
Timeframe: Pretransplant and 5 year Post Transplant

InterventionParticipants (Count of Participants)
Pretransplant NMO ASSAY positive5 year post transplant NMO Assay positive
Hematopoietic Stem Cell Transplantation112

[back to top]

Number of Patients Who Require No Device Assistance for Ambulation

No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
Pre HSCT- No Assistive Required6 Mos Post HSCT- No Assistive Device Required1 Year Post HSCT- No Assistive Device Required2 Year Post HSCT- No Assistive Device Required3 Year Post HSCT- No Assistive Device Required4 Year Post HSCT- No Assistive Device Required5 Year Post HSCT- No Assistive Device Required
Hematopoietic Stem Cell Transplantation69109889

[back to top]

Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months

InterventionProbability of 12-month RFS (Number)
Treatment0.83

[back to top]

Overall Survival (OS)

OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

InterventionProbability of surviving 12 months (Number)
Treatment0.88

[back to top]

Continuous Complete Remission (CCR) Rate

Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Treatment57

[back to top]

Vertigo Attacks

The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines). (NCT00802529)
Timeframe: 6month pre-enrollment baseline, 18-24 months after initial treatment

,
InterventionVertigo Attacks (Mean)
Baseline18-24months
Gentamicin19.932.5
Steroid (Methylprednisolone)16.41.6

[back to top]

Change in Hearing

Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz. (NCT00802529)
Timeframe: Baseline, 1,2,6,12,18 and 24months after initial treatment

,
InterventiondB (Mean)
Baseline1month2months6months12months18months24months
Gentamicin51.552.1848.9945.4847.3444.8249.1
Steroid (Methylprednisolone)53.2549.2949.8346.6747.0248.4446.9

[back to top]

Change in Speech Discrimination

"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score." (NCT00802529)
Timeframe: Baseline, 1,2,6,12 and 24months after initial treatment

,
InterventionPercentage correct (Mean)
Baseline1month2months6months12months24months
Gentamicin72.1069.4374.3176.3571.5864.99
Steroid (Methylprednisolone)64.9771.7876.1075.6373.4376.32

[back to top]

Overall Response

Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count. (NCT00806598)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.

Interventionparticipants (Number)
Complete ResponsePartial ResponseHematological Improvement
Thymoglobulin + Cyclosporin884

[back to top]

Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks

Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication (NCT00807586)
Timeframe: 6 weeks

InterventionParticipants (Count of Participants)
Steroid4
Placebo12

[back to top]

Repeat Intervention

Need for repeat ablation (NCT00807586)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Steroid2
Placebo8

[back to top]

Cardiac Pain Assessment

Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) (NCT00807586)
Timeframe: one day and one week

,
Interventionunits on a scale (Mean)
Pain Scale Day 1Pain Scale Week 1
Placebo1.50.6
Steroid0.90.8

[back to top]

Means Aqueous Humor Prednisolone Acetate Concentration

(NCT00854061)
Timeframe: 35 days

Interventionng/mL (Mean)
T-Pred100.02
Pred Forte131.65

[back to top]

Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%

Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%. (NCT00908583)
Timeframe: 46 days

Interventionparticipants (Number)
All Study Participants6

[back to top]

Number of Living Donor Transplant Candidates That Are Transplanted

Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted (NCT00908583)
Timeframe: 1 year post baseline

Interventionparticipants (Number)
All Study Participants19

[back to top]

Acute Rejection Rate

Acute rejection rate at 6 months of all desensitized and transplanted patients (NCT00908583)
Timeframe: 6 months post transplant

Interventionparticipants (Number)
All Transplanted Participants3

[back to top]

Overall Safety of Bortezomib

Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD). (NCT00908583)
Timeframe: Study Day 62

,,,,,,,
Interventionparticipants (Number)
Incidence of CTCAE Grade 3 Anemia (<8.0-6.5 g/dL)Incidence of CTCAE Grade 4 Anemia (<6.5g/dL)Incidence of CTCAE Grade 3 ThrombocytopeniaIncidence of CTCAE Grade 4 ThrombocytopeniaIncidence of CTCAE Grade 3 NeutropeniaIncidence of CTCAE Grade 4 NeutropeniaIncidence of new onset level 1 PNIncidence of new onset level 2 PNIncidence of new onset level 3 PNIncidence of new onset level 4 PNIncidence of new onset level 5 PNCMV D+/R- StatusCMV Viremia or Invasive DiseasePolyomavirus Allograft Nephropathy (PVN)Malignancy
Phase 1 Cycle 2202010033100000
Phase 1, Cycle 1101000151010000
Phase 2 Cycle 2000000230000000
Phase 2, Cycle 1100000320100000
Phase 3, Cycle 1001000021000000
Phase 3, Cycle 2001000110010000
Phase 4, Single Stage000000000000000
Phase 5, Single Stage100000100000000

[back to top]

Mean Number of Days With Acute Medication Use

"Acute medication use meant the consumption of a drug to abort or terminate a headache." (NCT00915473)
Timeframe: 4 weeks post-injection

Interventiondays per 4 weeks (Mean)
Active Injection6.7
Placebo Injection7.7

[back to top]

Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period

The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection. (NCT00915473)
Timeframe: 4 weeks pre-injection baseline, 4 weeks post-injection

Interventionparticipants (Number)
Active Injection10
Placebo Injection9

[back to top]

Mean Frequency of Days With a Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

,
Interventiondays per 4 weeks (Mean)
SevereAt Least ModerateAt Least Mild
Active Injection3.47.09.3
Placebo Injection2.97.810.4

[back to top]

Mean Number of Hours With Moderate or Severe Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

Interventionhours per 4 weeks (Mean)
Active Injection60
Placebo Injection58

[back to top]

Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. (NCT00929695)
Timeframe: At day 42 after initiation of treatment

Interventionmilligrams per kilogram (Mean)
Grade IIa GVHD; 0.5 mg/kg/d Prednisone22.2
Grade IIa GVHD; 1.0 mg/kg/d Prednisone27.1
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone38.4
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone41.3

[back to top]

Non-relapse Mortality

Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)15
Group B (Standard-dose)16

[back to top]

Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)77
Group B (Standard-dose)77

[back to top]

Prednisone-associated Toxicity as Assessed by Hyperglycemia

Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmg/dL (Mean)
Group A (Low-dose)140
Group B (Standard-dose)142

[back to top]

Prednisone-associated Toxicity as Assessed by Hypertension

The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmedications (Mean)
Group A (Low-dose)-0.29
Group B (Standard-dose)-0.24

[back to top]

Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. (NCT00929695)
Timeframe: Baseline and through 100 days of treatment

Interventionpercentage of participants (Number)
Group A (Low-dose)52
Group B (Standard-dose)53

[back to top]

Prednisone-associated Toxicity as Assessed by Myopathy

Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. (NCT00929695)
Timeframe: Baseline and then weekly until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-0.18
Group B (Standard-dose)-0.18

[back to top]

Prednisone-associated Toxicity as Assessed by Quality of Life

Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then every other week until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-2.3
Group B (Standard-dose)-1.9

[back to top]

Progression to Grade III-IV Acute GVHD

Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)6
Group B (Standard-dose)13

[back to top]

Recurrent or Progressive Malignancy

Percentage of relapse estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)21
Group B (Standard-dose)21

[back to top]

Secondary Therapy for Acute GVHD Beyond Prednisone

This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)23
Group B (Standard-dose)7

[back to top]

Chronic Extensive GVHD

Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)47
Group B (Standard-dose)54

[back to top]

Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

"The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Second follow-up visit (Day 5-28)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol93.86.30

[back to top]

Treatment Status (Success/Failure) of CD at the First Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: First follow-up visit (between Day 6 to 10 after start of treatment)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol52.5047.50

[back to top]

Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits

Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol7.3-4.2-6.3-7.1-7.2

[back to top]

Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Final follow-up visit (between Day 25 to 35 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

[back to top]

Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits

Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol6.8-4.1-6.2-6.7-6.8

[back to top]

Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits

Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred). (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol9.2-5.6-8.3-9.0-9.1

[back to top]

Treatment Status (Success/Failure) of CD at the Third Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Third follow-up visit (between Day 6 to 10 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

[back to top]

Total Intake/Output of Fluid

Total amount of all fluids in and out during the first 36 hours postoperatively in mL. (NCT00934843)
Timeframe: over 36 hours

,
InterventionmL (Mean)
Total Fluid in at 36 hrTotal Fluid out at 36 hr
MP Single Dose575600
MP Two Dose586558

[back to top]

Urine Output

Total urine output in mL over the first 36 hours after cardiac surgery (NCT00934843)
Timeframe: over 36 hours

InterventionmL (Mean)
MP Single Dose498
MP Two Dose453

[back to top]

Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery (NCT00934843)
Timeframe: at 36 hours and 30 days

Interventionparticipants (Number)
MP Single Dose1
MP Two Dose0

[back to top]

Inotropic Score

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score. (NCT00934843)
Timeframe: over the first 36 hours after surgery

InterventionScores on a scale (Mean)
MP Single Dose14.4
MP Two Dose15.0

[back to top]

Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support. (NCT00934843)
Timeframe: 36 hours

Interventionparticipants (Number)
MP Single Dose17
MP Two Dose15

[back to top]

Pain(at 6 Months): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.366
Local Corticosteroid Injection Group1.233

[back to top]

Pain (at 1 Week): Visual Analogue Scale(0 to 10)

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever." (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group7.166
Local Corticosteroid Injection Group4.5

[back to top]

Pain(at 1 Week): Nirschl Staging (0 to 7)

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group5.1
Local Corticosteroid Injection Group3.06

[back to top]

Pain(at 12 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.433
Local Corticosteroid Injection Group1.03

[back to top]

Pain(at 12 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.6
Local Corticosteroid Injection Group1.5

[back to top]

Pain(at 4 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group2.2
Local Corticosteroid Injection Group1.03

[back to top]

Pain(at 4 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group3.2
Local Corticosteroid Injection Group1.533

[back to top]

Pain(at 6 Months): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.533
Local Corticosteroid Injection Group1.833

[back to top]

Serum Total Testosterone Measured on Treatment Day 2

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 2

Interventionng/dL (Mean)
Testosterone Injection980.86
Testosterone Gel526.71
Medrol 6 Day Dose Pack191.87
Testosterone Injection and Medrol 6 Day Dose Pack675.86

[back to top]

Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 1

Interventionng/dL (Mean)
Testosterone Injection307.57
Testosterone Gel363.43
Medrol 6 Day Dose Pack408.17
Testosterone Injection and Medrol 6 Day Dose Pack318.68

[back to top]

Serum Estradiol Measured on Treatment Day 8 (Post Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionpg/mL (Mean)
Testosterone Injection48.29
Testosterone Gel33.43
Medrol 6 Day Dose Pack30.83
Testosterone Injection and Medrol 6 Day Dose Pack47.14

[back to top]

Serum Estradiol Measured on Treatment Day 1 (Baseline Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionpg/mL (Mean)
Testosterone Injection22.86
Testosterone Gel33.69
Medrol 6 Day Dose Pack36.33
Testosterone Injection and Medrol 6 Day Dose Pack34.71

[back to top]

Serum Total Testosterone Measured on Treatment Day 4

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 4

Interventionng/dL (Mean)
Testosterone Injection779.57
Testosterone Gel441.71
Medrol 6 Day Dose Pack271.6
Testosterone Injection and Medrol 6 Day Dose Pack734.57

[back to top]

C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.33
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.4

[back to top]

Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection1.98
Testosterone Gel2.32
Medrol 6 Day Dose Pack1.78
Testosterone Injection and Medrol 6 Day Dose Pack2.07

[back to top]

Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection1.92
Testosterone Gel2.33
Medrol 6 Day Dose Pack1.85
Testosterone Injection and Medrol 6 Day Dose Pack1.83

[back to top]

Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection104.0
Testosterone Gel94.57
Medrol 6 Day Dose Pack87.5
Testosterone Injection and Medrol 6 Day Dose Pack75.14

[back to top]

C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.31
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.3

[back to top]

Insulin Measured on Treatment Day 8 (Post Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 8

InterventionuIu/mL (Mean)
Testosterone Injection7.47
Testosterone Gel10.58
Medrol 6 Day Dose Pack3.92
Testosterone Injection and Medrol 6 Day Dose Pack3.89

[back to top]

Insulin Measured on Treatment Day 1 (Baseline Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 1

InterventionuIu/mL (Mean)
Testosterone Injection8.53
Testosterone Gel10.28
Medrol 6 Day Dose Pack4.09
Testosterone Injection and Medrol 6 Day Dose Pack9.89

[back to top]

Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection80.16
Testosterone Gel72.11
Medrol 6 Day Dose Pack69.17
Testosterone Injection and Medrol 6 Day Dose Pack54.86

[back to top]

Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.71
Testosterone Gel7.20
Medrol 6 Day Dose Pack4.76
Testosterone Injection and Medrol 6 Day Dose Pack4.15

[back to top]

Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection28
Testosterone Gel33.14
Medrol 6 Day Dose Pack24.67
Testosterone Injection and Medrol 6 Day Dose Pack23.86

[back to top]

Triglycerides Measured on Treatment Day 8 (Post Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection112.57
Testosterone Gel160.0
Medrol 6 Day Dose Pack155.17
Testosterone Injection and Medrol 6 Day Dose Pack116.28

[back to top]

Triglycerides Measured on Treatment Day 1 (Baseline Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection140.42
Testosterone Gel164.0
Medrol 6 Day Dose Pack122.5
Testosterone Injection and Medrol 6 Day Dose Pack119.71

[back to top]

Total Cholesterol Measured on Treatment Day 8 (Post Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection172
Testosterone Gel162.86
Medrol 6 Day Dose Pack166.17
Testosterone Injection and Medrol 6 Day Dose Pack141.86

[back to top]

Total Cholesterol Measured on Treatment Day 1 (Baseline Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection171.29
Testosterone Gel165.57
Medrol 6 Day Dose Pack168.00
Testosterone Injection and Medrol 6 Day Dose Pack156.71

[back to top]

Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection71.77
Testosterone Gel69.2
Medrol 6 Day Dose Pack61.42
Testosterone Injection and Medrol 6 Day Dose Pack90.74

[back to top]

High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection41.29
Testosterone Gel36.71
Medrol 6 Day Dose Pack47.67
Testosterone Injection and Medrol 6 Day Dose Pack43.43

[back to top]

High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection40.29
Testosterone Gel38.86
Medrol 6 Day Dose Pack46.50
Testosterone Injection and Medrol 6 Day Dose Pack42.14

[back to top]

Hematocrit Measured on Treatment Day 8 (Post Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 8

Interventionpercent (Mean)
Testosterone Injection38.74
Testosterone Gel37.23
Medrol 6 Day Dose Pack40.53
Testosterone Injection and Medrol 6 Day Dose Pack39.24

[back to top]

Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 1

Interventionnmol/L (Mean)
Testosterone Injection21.78
Testosterone Gel19.86
Medrol 6 Day Dose Pack25.66
Testosterone Injection and Medrol 6 Day Dose Pack24.70

[back to top]

Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 8

Interventionng/dL (Mean)
Testosterone Injection454.29
Testosterone Gel435.14
Medrol 6 Day Dose Pack340.17
Testosterone Injection and Medrol 6 Day Dose Pack481.14

[back to top]

Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection103.0
Testosterone Gel93.57
Medrol 6 Day Dose Pack96.83
Testosterone Injection and Medrol 6 Day Dose Pack90.71

[back to top]

Hematocrit Measured on Treatment Day 1 (Baseline Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 1

Interventionpercent (Mean)
Testosterone Injection39.17
Testosterone Gel38.4
Medrol 6 Day Dose Pack40.45
Testosterone Injection and Medrol 6 Day Dose Pack39.86

[back to top]

Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1." (NCT00957801)
Timeframe: Study days -7 to -1 (Pre - treatment)

Interventionunits on a scale (Mean)
Testosterone Injection2.25
Testosterone Gel1.47
Medrol 6 Day Dose Pack2.26
Testosterone Injection and Medrol 6 Day Dose Pack1.86

[back to top]

Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8." (NCT00957801)
Timeframe: Study days 1-7 (treatment week)

Interventionunits on a scale (Mean)
Testosterone Injection1.84
Testosterone Gel1.79
Medrol 6 Day Dose Pack2.19
Testosterone Injection and Medrol 6 Day Dose Pack1.57

[back to top]

Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionug/dL (Mean)
Testosterone Injection37.96
Testosterone Gel35.54
Medrol 6 Day Dose Pack34.74
Testosterone Injection and Medrol 6 Day Dose Pack36.07

[back to top]

Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionug/dL (Mean)
Testosterone Injection46.34
Testosterone Gel34.16
Medrol 6 Day Dose Pack62.55
Testosterone Injection and Medrol 6 Day Dose Pack46.07

[back to top]

Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection26.71
Testosterone Gel29.29
Medrol 6 Day Dose Pack31.0
Testosterone Injection and Medrol 6 Day Dose Pack24.71

[back to top]

Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.84
Testosterone Gel5.97
Medrol 6 Day Dose Pack6.28
Testosterone Injection and Medrol 6 Day Dose Pack5.19

[back to top]

Serum Total Testosterone Measured on Treatment Day 7

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 7

Interventionng/dL (Mean)
Testosterone Injection578.29
Testosterone Gel485.86
Medrol 6 Day Dose Pack320.0
Testosterone Injection and Medrol 6 Day Dose Pack579.57

[back to top]

Serum Total Testosterone Measured on Treatment Day 6

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 6

Interventionng/dL (Mean)
Testosterone Injection629.0
Testosterone Gel536.43
Medrol 6 Day Dose Pack284.5
Testosterone Injection and Medrol 6 Day Dose Pack645.14

[back to top]

Serum Total Testosterone Measured on Treatment Day 5

"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 5

Interventionng/dL (Mean)
Testosterone Injection722.0
Testosterone Gel460.14
Medrol 6 Day Dose Pack246.33
Testosterone Injection and Medrol 6 Day Dose Pack669.71

[back to top]

Serum Total Testosterone Measured on Treatment Day 3

"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 3

Interventionng/dL (Mean)
Testosterone Injection828.71
Testosterone Gel527.43
Medrol 6 Day Dose Pack206.0
Testosterone Injection and Medrol 6 Day Dose Pack673.29

[back to top]

Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.05
Testosterone Gel6.28
Medrol 6 Day Dose Pack4.40
Testosterone Injection and Medrol 6 Day Dose Pack5.78

[back to top]

Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.25
Testosterone Gel6.00
Medrol 6 Day Dose Pack6.64
Testosterone Injection and Medrol 6 Day Dose Pack6.28

[back to top]

Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 8

Interventionnmol/L (Mean)
Testosterone Injection17.62
Testosterone Gel20.13
Medrol 6 Day Dose Pack19.22
Testosterone Injection and Medrol 6 Day Dose Pack14.57

[back to top]

Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)

Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. (NCT00968253)
Timeframe: Up to 20 cycles of study drugs (21 day cycles) or till disease progression

,,
Interventionparticipants (Number)
Complete RemissionComplete Remission without platelet recoveryCR with incomplete blood count recoveryPartial RemissionNonresponder
Phase I: RAD001 10 mg + Combination Chemo20115
Phase I: RAD001 5 mg + Combination Chemo10011
Phase II: MTD RAD001 + Combination Chemo31008

[back to top]

Overall Response Rate (OR) Where OR = CR + CRp + CRi

Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. (NCT00968253)
Timeframe: 8 courses of treatment, up to 24 weeks

Interventionpercentage of participants (Number)
Phase I: RAD001 5 mg + Combination Chemo33
Phase I: RAD001 10 mg + Combination Chemo33
Phase II: MTD RAD001 + Combination Chemo33

[back to top]

Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)

"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs." (NCT00968253)
Timeframe: Following first two dose cycles (21 days/each), up to 42 days

InterventionParticipants (Count of Participants)
Phase I: RAD001 5 mg + Combination Chemo0
Phase I: RAD001 10 mg + Combination Chemo1

[back to top]

Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).

(NCT00987831)
Timeframe: 12 months

Interventiondays to flare (Median)
Severe Disease Activity at Baseline40
Moderate Disease Activity at Baseline72.5

[back to top]

Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline

Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI 3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures (NCT00987831)
Timeframe: 12 months

Interventiondays to flare (Median)
Severe Disease Activity at Baseline45
Moderate Disease Activity at Baseline71

[back to top]

Change in Bone Density (in Participants Untreated With Bisphosphonates)

Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. (NCT01000610)
Timeframe: Screening and Week 84

Interventiont-score (Number)
ScreeningWeek 84
Rituximab-1.82-1.6

[back to top]

Number of Participants Reporting Adverse Events (AEs)

(NCT01000610)
Timeframe: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Interventionnumber of participants (Number)
Participants who experienced an AEParticipants who experienced more than 1 AE
Rituximab117

[back to top]

Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage change from baseline (Mean)
Rituximab-1.7

[back to top]

Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Rituximab75.0

[back to top]

Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01085097)
Timeframe: Baseline up to Week 28

Interventionparticipants (Number)
Placebo14
Laquinimod 0.5 mg15
Laquinimod 1 mg15

[back to top]

Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula. (NCT01085097)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
Placebo12.1
Laquinimod 0.5 mg18.0
Laquinimod 1 mg24.3

[back to top]

Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: two years post transplant

InterventionParticipants (Count of Participants)
Arm I2

[back to top]

Overall Survival

Number of participants alive at 180 days post engraftment. (NCT01093586)
Timeframe: On day +180

InterventionParticipants (Count of Participants)
Arm I8

[back to top]

Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

[back to top]

Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: one year in patients post UCBT

InterventionParticipants (Count of Participants)
Arm I2

[back to top]

Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I6

[back to top] [back to top] [back to top] [back to top]

Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

[back to top]

Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I4

[back to top]

Incidence of Acute Graft-versus-host Disease (GVHD)

Number of participants that had acute GVHD (NCT01093586)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Arm I11

[back to top]

Occurrence of Serious Infections

Number of participants that had infections (NCT01093586)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm I13

[back to top]

Incidence of Chronic GVHD

Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I1

[back to top]

Hematologic Engraftment

Number of participants that were able to complete engraftment by day 42. (NCT01093586)
Timeframe: On day +42

InterventionParticipants (Count of Participants)
Arm I10

[back to top]

Time to Disease Progression

Time from study entry until progressive disease or data collection cutoff. (NCT01105650)
Timeframe: 1 Year

Interventiondays (Median)
Arm 1: CsA52
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-298
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2100

[back to top]

Response Rate

Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease. (NCT01105650)
Timeframe: Month 3

Interventionparticipants (Number)
Arm 1: CsA1
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-22
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-24

[back to top]

Overall Survival

Number of participants alive at 1 year. (NCT01105650)
Timeframe: 1 Year

Interventionparticipants (Number)
Arm 1: CsA0
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-23

[back to top]

Number of Participants With Progressive Disease at One Year

(NCT01105650)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Arm 1: CsA2
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-25

[back to top]

Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC

Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC

The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24. (NCT01114503)
Timeframe: Up to Week 24

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC

The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC

The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Upto Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)

The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 - 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 - 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 - 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 - 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC

ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec. (NCT01114503)
Timeframe: Screening (Day -35 to Day -1)

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top]

Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC

The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12. (NCT01114503)
Timeframe: Week 2 to Week 12

InterventionParticipants (Number)
Otelixizumab Cohort A10

[back to top] [back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon

Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity

Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL92.37.70.00.094.95.10.00.094.95.10.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE87.512.50.00.090.07.52.50.090.010.00.00.097.52.50.00.097.52.50.00.097.52.50.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection

Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL46.248.72.62.679.520.50.00.089.710.30.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE25.065.010.00.077.522.50.00.092.57.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade

Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 1: Grade 4Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 8: Grade 4Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 15: Grade 4Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 3Day 29: Grade 41 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 31 Week After Last Dose: Grade 4Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3Month 3: Grade 4
DUREZOL23.757.915.82.60.055.336.85.32.60.078.918.40.02.60.089.510.50.00.00.097.42.60.00.00.094.75.30.00.00.0
PRED FORTE40.030.027.50.02.557.532.510.00.00.077.517.55.00.00.095.02.52.50.00.095.02.52.50.00.097.50.02.50.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation

Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL64.130.85.10.094.95.10.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE72.522.55.00.097.52.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia

Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL71.820.57.70.089.710.30.00.097.42.60.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE60.035.05.00.087.510.02.50.095.05.00.00.092.55.00.02.597.52.50.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity

Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 1: Grade 0Month 1: Grade 1Month 1: Grade 2Month 1: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment Score of Postoperative Inflammation by Visit

A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 29: Grade 0Day 29: Grade 1Day 29: Grade 21 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 2Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2
DUREZOL30.869.20.048.748.72.656.443.60.079.520.50.089.77.72.692.35.12.6
PRED FORTE17.582.50.025.070.05.050.050.00.072.525.02.590.07.52.592.57.50.0

[back to top]

Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days

Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. (NCT01124045)
Timeframe: Day 15 ± 2 days

InterventionPercentage of patients (Number)
DUREZOL78.9
PRED FORTE77.5

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade

Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL41.051.37.70.061.535.92.60.074.417.97.70.087.212.80.00.094.92.62.60.092.35.12.60.0
PRED FORTE45.037.512.55.052.540.05.02.570.027.52.50.092.57.50.00.092.57.50.00.095.05.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis

Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL82.115.40.02.697.42.60.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE85.015.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection

Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL69.228.20.02.689.710.30.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE57.540.02.50.090.010.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0

[back to top]

Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis

Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE97.52.50.00.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.0

[back to top]

Change in Levels of Serum IL-6

(NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionpg/ml (Mean)
Infliximab-0.4
Salt Water8.1
Methylprednisolone Acetate5.5

[back to top]

Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee

The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities. (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab-25.9
Normal Saline-9.3
Methylprednisolone Acetate2.0

[back to top]

Change in Joint Effusions From Day 0 to Day 56 Target Knee

"Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive bulge, 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points." (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab0.3
Salt Water0.0
Methylprednisolone Acetate0.0

[back to top]

Change in Serum CRP Day 0 to Day 56

Serum measure of systemic inflammation (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionmg/dl (Mean)
Infliximab-0.18
Salt Water-0.15
Methylprednisolone Acetate0.08

[back to top]

Change in Serum SAA Levels Day 0 to Day 56

Serum Amyloid A (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionug/ml (Mean)
Infliximab-1.0
Salt Water-715.6
Methylprednisolone Acetate-1580.2

[back to top]

Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.041.378.382.680.482.680.4
Pred Forte14.940.461.776.676.676.678.7

[back to top]

Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol7.1-3.5-5.2-6.1-6.5-6.4-6.3-6.2
Pred Forte7.3-3.6-5.0-5.8-6.2-6.2-6.2-6.3

[back to top]

Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol2.2-1.1-1.6-2.0-2.0-2.0-2.0-2.0
Pred Forte2.3-1.2-1.6-1.9-2.0-2.0-2.0-2.0

[back to top]

Proportion of Subjects With Anterior Chamber Cell Count of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.021.752.273.973.969.669.6
Pred Forte2.121.338.348.963.863.868.1

[back to top]

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 14

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 14
Durezol2.6-2.2
Pred Forte2.6-2.0

[back to top]

Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Time to Event

InterventionPercentage of subjects (Number)
Durezol0
Pred Forte14.9

[back to top]

Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol186.7-88.4-108.2-133.3-138.8-140.1-143.9-146.2
Pred Forte203.2-88.4-123.8-137.4-149.5-152.4-147.3-155.5

[back to top]

Proportion of Subjects With Anterior Chamber Cell Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol15.234.865.284.880.478.376.1
Pred Forte6.425.555.363.870.270.274.5

[back to top]

Proportion of Subjects With Anterior Chamber Cell Grade ≤1

As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol50.087.093.593.593.593.591.3
Pred Forte57.480.985.189.487.285.185.1

[back to top]

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 21Day 28Day 35Day 42
Durezol2.6-1.1-1.8-2.4-2.3-2.3-2.3
Pred Forte2.6-1.0-1.6-2.1-2.1-2.1-2.1

[back to top]

Severity of AEs and SAEs

AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionevents (Number)
Mild SAEModerate SAESevere SAEMild AEModerate AESevere AE
IVMP With Oral Prednisolone Taper110510
Pulsed IVMP112330

[back to top]

Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)

Following the completion of rapid removal of natalizumab using PLEX or equivalent. (NCT01211665)
Timeframe: 6 months

Interventionparticipants (Number)
Pulsed IVMP1
IVMP With Oral Prednisolone Taper1

[back to top]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionparticipants (Number)
AEsSAEs
IVMP With Oral Prednisolone Taper11
Pulsed IVMP22

[back to top]

DAS28-ESR During the Noninterventional Phase

DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab5.83.3-2.7

[back to top]

HAQ-DI During the Interventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=41)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab1.00.80.0

[back to top]

Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=66)V2 (n=61)Change from V1 to V2 (n=60)
Tocilizumab1.71.2-0.5

[back to top]

Median GC Dose Taken During the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg (Median)
Start dose V1 (n=68)Start dose (V1) for Interventional phase (n=50)Stop dose (V2; n=50)Change from start to stop (n=50)Cumulative dose from V1 to V2 (n=45)
Tocilizumab6640320

[back to top]

Number of Erosions During the NonInterventional Phase

In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionerosions (Mean)
V1 (n=11)Between V1 and V2 (n=6)
Tocilizumab5.13.2

[back to top]

Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase

Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=20)Between V1 and V2 (n=6)
Tocilizumab75.083.3

[back to top]

Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=39)Between V1 and V2 (n=21)
Tocilizumab56.452.4

[back to top]

Percentage of Participants With Erosions During the NonInterventional Phase

In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=57)Between V1 and V2 (n=36)
Tocilizumab47.441.7

[back to top]

Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=40)V3 Remission (n=40)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=38)V5 Remission (n=38)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=31)V8 Remission (n=31)V9 LDA (n=29)V9 Remission (n=29)CV LDA (n=27)CV Remission (n=27)
Tocilizumab85.027.582.939.081.647.471.437.175.833.380.638.769.031.077.833.3

[back to top]

Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=42)V3 Remission (n=42)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=35)V5 Remission (n=35)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=32)V8 Remission (n=32)V9 LDA (n=30)V9 Remission (n=30)CV LDA (n=27)CV Remission (n=27)
Tocilizumab90.573.885.473.288.671.482.962.990.957.687.562.573.356.788.959.3

[back to top]

SF-36 Subscale Scores During the Interventional Phase

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
Physical functioning V3 (n=36)Physical functioning CV (n=26)Change in physical functioning V3 to CV (n=22)Physical sub-score V3 (n=37)Physical sub-score CV (n=26)Change in physical sub-score V3 to CV (n=22)Bodily pain V3 (n=37)Bodily pain CV (n=26)Change in bodily pain V3 to CV (n=22)General health V3 (n=37)General health CV (n=26)Change in general health V3 to CV (n=22)Vitality V3 (n=37)Vitality CV (n=26)Change in vitality V3 to CV (n=22)Social functioning V3 (n=37)Social functioning CV (n=26)Change in social functioning V3 to CV (n=22)Emotional sub-score V3 (n=37)Emotional sub-score CV (n=26)Change in emotional sub-score V3 to CV (n=22)Mental health V3 (n=37)Mental health CV (n=26)Change in Mental health V3 to CV (n=22)
Tocilizumab41.5241.92-1.8040.6139.85-2.7945.8844.65-3.2143.1140.82-3.7850.5148.91-4.3745.4245.58-2.7340.5940.37-2.4547.1445.94-5.47

[back to top]

Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase

"36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
MCS V3 (n=37)MCS CV (n=26)MCS: Change from V3 to CV (n=22)PCS V3 (n=36)PCS CV (n=26)PCS: Change from V3 to CV (n=22)
Tocilizumab47.046.2-4.442.541.8-2.1

[back to top]

SJC and TJC During the Interventional Phase

TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionjoints (Mean)
SJC V3 (n=43)SJC CV (n=29)SJC Change from V3 to CV (n=29)TJC V3 (n=43)TJC CV (n=29)TJC Change from V3 to CV (n=29)
Tocilizumab0.90.4-0.30.91.81.0

[back to top]

Type of GC Taken at the End of the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
MPPrednisolonePrednisone
Tocilizumab70.028.02.0

[back to top]

VAS for Pain (VAS-Pain) During the Interventional Phase

Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=43)CV (n=28)Change from V3 to CV (n=28)
Tocilizumab19.924.96.9

[back to top]

VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase

Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=40)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab16.616.73.1

[back to top]

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=37)CV (n=26)Change from V3 to CV (n=22)
Tocilizumab37.535.68.8

[back to top]

Median Dose of Tocilizumab During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg/kg (Median)
Tocilizumab8.0

[back to top]

Median Time Interval Between V1 and V2

The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmonths (Median)
Tocilizumab2.3

[back to top]

Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase

The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab1

[back to top]

Number of Participants With GC Switches During the Noninterventional Phase

During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab0

[back to top]

Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab72.1

[back to top]

Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab3.3

[back to top]

Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab93.3

[back to top]

Percentage of Participants Able to Start the GC Reduction Phase at V3

All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC. (NCT01219933)
Timeframe: V3 (7 months)

Interventionpercentage of participants (Number)
Tocilizumab87.8

[back to top]

Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab41.2

[back to top]

Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Interventionpercentage of participants (Number)
Tocilizumab58.1

[back to top]

Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab15.2

[back to top]

Time-Averaged GC Dose Changes During the Interventional Phase

"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmg (Mean)
Tocilizumab341.8

[back to top]

CDAI Score During the Interventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=40)CV (n=27)Change from V3 to CV (n=25)
Tocilizumab5.66.51.4

[back to top]

Clinical Disease Activity Index (CDAI) During the Noninterventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab33.814.6-20.4

[back to top]

DAS28-CRP During the Interventional Phase

DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=42)CV (n=27)Change from V3 to CV (n=27)
Tocilizumab2.22.30.2

[back to top]

DAS28-CRP During the Noninterventional Phase

DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=67)V2 (n=66)Change from V1 to V2 (n=65)
Tocilizumab5.42.9-2.5

[back to top]

Pain Numeric Rating Scale

Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week. (NCT01238536)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Epidural Steroid Injection4.4
Epidural Local Anesthetic Injection4.6

[back to top]

Leg Pain NRS

Leg Pain NRS 0-10 scale (NCT01238536)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Epidural Steroid Injection4.7
Epidural Local Anesthetic Injection4.3

[back to top]

Roland Morris

The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. (NCT01238536)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Epidural Steroid Injection11.8
Epidural Local Anesthetic Injection12.5

[back to top]

Roland Morris Disability Questionnaire (RDQ)

The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection. (NCT01238536)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Epidural Steroid Injection12.0
Epidural Local Anesthetic Injection11.5

[back to top]

Maximum Observed Plasma Concentration (Cmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionng/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet289.00
Methylprednisolone 32 mg Micronized API279.10
Methylprednisolone 32 mg Sieve Cut API246.20

[back to top]

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose

Interventionng*hr/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet1286.00
Methylprednisolone 32 mg Micronized API1204.00
Methylprednisolone 32 mg Sieve Cut API1180.00

[back to top]

Plasma Decay Half-life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Mean)
Methylprednisolone 32 mg Tablet2.43
Methylprednisolone 32 mg Micronized API2.42
Methylprednisolone 32 mg Sieve Cut API2.45

[back to top]

Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Median)
Methylprednisolone 32 mg Tablet2.00
Methylprednisolone 32 mg Micronized API1.00
Methylprednisolone 32 mg Sieve Cut API2.00

[back to top]

Urgent Care Visits, ED Visits and Hospitalizations

Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms. (NCT01272635)
Timeframe: 14 days after initiation of therapy

Interventionparticipants (Number)
Azythromycin20
Placebo38

[back to top]

Progression to Clinically Significant Lower Respiratory Tract Symptoms

Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated. (NCT01272635)
Timeframe: 14 days after initiation of APRIL therapy

Interventionparticipants (Number)
Azythromycin35
Placebo57

[back to top]

OCELOT: Pediatric Respiratory Assessment Measure

The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80. (NCT01272635)
Timeframe: 36-72 hours after initiation of OCELOT therapy

InterventionPRAM score (Mean)
Prednisone0.82
Placebo1.00

[back to top] [back to top] [back to top]

60-day Mortality

The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60. (NCT01283009)
Timeframe: 60-day

InterventionParticipants (Count of Participants)
Died on or prior to study day 6072325123Died on or prior to study day 6072325124On Mechanical Ventilation at Study Entry72325123On Mechanical Ventilation at Study Entry72325124Not on Mechanical Ventilation72325123Not on Mechanical Ventilation72325124
YesNoUnknown
Arm 1: Inactive Substance50
Arm 2: Methylprednisolone47
Arm 1: Inactive Substance227
Arm 2: Methylprednisolone239
Arm 1: Inactive Substance10
Arm 2: Methylprednisolone11
Arm 1: Inactive Substance24
Arm 2: Methylprednisolone22
Arm 1: Inactive Substance70
Arm 2: Methylprednisolone72
Arm 1: Inactive Substance2
Arm 2: Methylprednisolone3
Arm 1: Inactive Substance26
Arm 2: Methylprednisolone25
Arm 1: Inactive Substance157
Arm 2: Methylprednisolone167
Arm 1: Inactive Substance8
Arm 2: Methylprednisolone8

[back to top]

Complete Response Duration

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

[back to top]

Number of Patients With Complete Remission at One Year

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. (NCT01319981)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Hyper-CMAD + Rituximab12
Hyper-CMAD13

[back to top]

Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

[back to top]

Change From Baseline in DAS28-CRP at 12 Weeks

"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores." (NCT01369745)
Timeframe: baseline to week 12

Interventionunits on a scale (Mean)
Prednisolone-1.147
Dipyridamole-0.813
Prednisone-1.237
Z102-0.907
Placebo-0.538

[back to top]

Progression-Free Survival (PFS)

Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years

InterventionMonths (Median)
Exemestane3.68
Abiraterone Acetate + Prednisone3.65
Abiraterone Acetate + Exemestane + Prednisone4.47

[back to top]

Overall Survival (OS)

OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years

InterventionMonths (Median)
ExemestaneNA
Abiraterone Acetate + Prednisone26.41
Abiraterone Acetate + Exemestane + PrednisoneNA

[back to top]

Duration of Response

Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years

Interventionmonths (Median)
Exemestane6.47
Abiraterone Acetate + Prednisone4.86
Abiraterone Acetate + Exemestane + Prednisone6.93

[back to top]

Clinical Benefit Rate

Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane12.7
Abiraterone Acetate + Prednisone9.6
Abiraterone Acetate + Exemestane + Prednisone22.7

[back to top]

Overall Response Rate (ORR)

Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane6.3
Abiraterone Acetate + Prednisone5.8
Abiraterone Acetate + Exemestane + Prednisone12.1

[back to top]

Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment

Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionPicomoles Per Liter (Pmol/L) (Mean)
EstradiolEstrone
Abiraterone Acetate + Exemestane + Prednisone-1.04-30.60
Abiraterone Acetate + Prednisone-3.35-28.09
Exemestane1.53-34.20

[back to top]

Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment

Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionNanomoles Per Liter (nmol/L) (Mean)
ProgesteroneTestosterone
Abiraterone Acetate + Exemestane + Prednisone12.34-0.48
Abiraterone Acetate + Prednisone8.98-0.51
Exemestane-4.80-0.09

[back to top]

Number of Eyes With Intraocular Pressure (IOP) Elevation

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. (NCT01448213)
Timeframe: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Interventioneyes (Number)
Fluorometholone 0.1% Solution9
Prednisolone Acetate 1% Solution32

[back to top]

Number of Eyes With Immunologic Graft Rejection Episodes

(NCT01448213)
Timeframe: Within 1 year

Interventioneyes (Number)
Fluorometholone 0.1% Solution2
Prednisolone Acetate 1% Solution0

[back to top]

Number of Participants With Overall CR

CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionparticipants (Number)
Treatment Naive2
Relapsed/Refractory0

[back to top]

Transplant Rate

Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT. (NCT01465334)
Timeframe: Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)

Interventionpercentage of participants (Number)
Treatment Naive43
Relapsed/Refractory43

[back to top]

Overall Objective Response Rate (ORR)

Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory67

[back to top]

3-year Overall Survival (OS) Probability

3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods. (NCT01465334)
Timeframe: Median survival follow-up was 45 months (range 31-58 months) in this study cohort.

Interventionpercentage probability (Number)
Treatment Naive66
Relapsed/Refractory53

[back to top]

3-Year Progression-Free Survival (PFS) Probability

3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology. (NCT01465334)
Timeframe: Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.

Interventionpercentage probability (Number)
Treatment Naive53
Relapsed/Refractory25

[back to top]

Induction Overall Response Rate (ORR)

Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionpercentage of participants (Number)
Treatment Naive73
Relapsed/Refractory60

[back to top]

Number of Participants Achieving Induction Complete Response (CR)

CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

[back to top]

Overall MRD Negative Rate

Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes. (NCT01465334)
Timeframe: MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory53

[back to top]

Number of Participants Completing Only 2 Cycles of Part A Treatment

Participants counted if only completed 2 cycles of Part A treatment per protocol. (NCT01465334)
Timeframe: Evaluated after 2 cycles/8 weeks of Part A therapy.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

[back to top]

Number of Participants Completing Part A Treatment

Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol. (NCT01465334)
Timeframe: Evaluated up to 4 cycles/16 weeks.

Interventionparticipants (Number)
Treatment Naive12
Relapsed/Refractory15

[back to top] [back to top]

Anterior Chamber Cells & Flare

"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance" (NCT01475643)
Timeframe: Over all visits 42 days

InterventionGrade of anterior chamber flare (Mean)
Loteprednol Etabonate.192
Prednisolones Acetate.341

[back to top]

Anterior Chamber Inflammation

"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished" (NCT01475643)
Timeframe: Postoperative Day 29

Interventiongrade of anterior chamber cells (Mean)
Loteprednol Etabonate.913
Prednisolones Acetate.783

[back to top]

Rate of Progression/Relapse Free Survival (PFS)

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier. (NCT01496976)
Timeframe: Up to 56 months

Interventionmonths (Median)
Immunotherapy54.4

[back to top]

Number of Participants With Partial Response (PR)

The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution. (NCT01496976)
Timeframe: 3 Months

Interventionparticipants (Number)
Immunotherapy33

[back to top]

Number of Participants With Overall Survival (OS)

Overall survival will be summarized with the Kaplan-Meier curve. (NCT01496976)
Timeframe: 36 Months

Interventionparticipants (Number)
Immunotherapy24

[back to top]

Number of Participants With Complete Response (CR)

Number of participants with complete response, the disappearance of all signs of cancer in response to treatment. (NCT01496976)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Immunotherapy1

[back to top]

Objective Response Rate (ORR)

ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) (NCT01497496)
Timeframe: 3 Months

Interventionpercentage of participants (Number)
Immunotherapy48.3

[back to top]

Conjunctival Redness Change From Baseline to Day 11

Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) (NCT01534195)
Timeframe: 7 Minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.69
Placebo0.40

[back to top]

Ocular Itching Change From Baseline to Day 11

Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). (NCT01534195)
Timeframe: 5 minutes post-CAC

Interventionunits on a scale (Mean)
Prednisolone-1.1
Placebo-0.45

[back to top]

Episcleral Redness Change From Baseline to Day 6

Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.0
Placebo0.45

[back to top]

Ciliary Redness Change From Baseline to Day 6

Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.94
Placebo0.30

[back to top]

Orthostatic Hypotension

(NCT01559675)
Timeframe: Postoperative Day 1

Interventionparticipants (Number)
High Dose Steroid2
Low Dose Steroid2

[back to top]

Duration of Mechanical Ventilation Post Cardiac Surgery.

Amount of time on mechanical ventilation following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Median)
Intraoperative Methylprednisone4
Placebo5

[back to top]

Intensive Care Unit Stay

Amount of time in the intensive care unit following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone11
Placebo11

[back to top]

Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome

The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population. (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionParticipants (Count of Participants)
Intraoperative Methylprednisone27
Placebo40

[back to top]

Neurodevelopmental Outcome

Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154. (NCT01579513)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
Cognitive DomainLanguage DomainMotor Domain
Intraoperative Methylprednisone10510190
Placebo10410091

[back to top]

Hospital Stay

Total duration of hospital stay following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone20
Placebo22

[back to top]

Reduction of Pain Severity Expressed as Percentage Change in VAS Score

"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of pain reduction (Mean)
Methylprednisolone Acetate Group82
Triamcinolone Acetonide Group96

[back to top]

Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values" (NCT01652495)
Timeframe: 45 days after treatment

Intervention% of patients with HPA suppression (Number)
Methylprednisolone Acetate Group0
Triamcinolone Acetonide Group15

[back to top]

Functional Improvement Measured According to Percentage Change in Constant Score

"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of improvement Constant score (Mean)
Methylprednisolone Acetate Group99
Triamcinolone Acetonide Group95

[back to top]

Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A11.47.07.17.09.012.516.023.813.310.06.57.73.5
Arm B15.618.223.514.79.710.211.610.911.012.613.48.76.3

[back to top]

Cancer Therapy Satisfaction Questionnaire (CTSQ) Score

CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Expectations of therapy domainFeelings about side effects domainSatisfaction with therapy domain
Rituximab Intravenous (IV)80.8860.6384.59
Rituximab Subcutaneous (SC)82.0761.6485.42

[back to top]

Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])

Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)

Interventionminutes (Median)
Rituximab Intravenous (IV)840
Rituximab Subcutaneous (SC)22

[back to top]

Progression-free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

[back to top]

Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)

Interventionpercentage of participants (Number)
Arm A79.1
Arm B80.6

[back to top]

Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

[back to top]

Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)

Interventionparticipants (Number)
Arm A352
Arm B347

[back to top]

Event-free Survival (EFS)

EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

[back to top]

Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)

Interventionpercentage of participants (Number)
Arm A77.1
Arm B84.2

[back to top]

Disease-free Survival (DFS)

DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

[back to top]

Complete Response (CR) Rate

CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment

Interventionpercentage of participants (Number)
Arm A49.2
Arm B52.7

[back to top]

Summary of Observed Serum Rituximab Concentration

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionmicrogram per milliter (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A3355.925053.162977.087956.6117273.6108030.9100927.795614.0104873.086806.67802.92380.19302.0
Arm B970.124541.146093.959485.577665.370387.398679.7117172.0137048.1120995.78042.91685.39553.9

[back to top]

Rituximab Administration Satisfaction Questionnaire (RASQ) Score

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Physical impact domainPsychological Impact domainImpact on activitiesf daily livingConvenience domainSatisfaction domain
Rituximab Intravenous (IV)82.1477.7359.4959.0574.88
Rituximab Subcutaneous (SC)82.0884.0081.8681.0587.26

[back to top]

Percentage of Participants With Anti-Rituximab Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A2.02.10.300000001.82.10.6
Arm B3.02.20.90.300000000.60.6

[back to top]

Inflammation Change From Baseline to Day 6

Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). (NCT01730872)
Timeframe: 90 minutes post CAC

Interventionscore on a scale (Mean)
Prednisolone-1.2
Placebo-0.19

[back to top]

Ocular Redness Change From Baseline to Day 6

Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo0.31

[back to top]

Ocular Itching Change From Baseline to Day 6

Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo-1.0

[back to top]

Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)26
Methylprednisolone7
Observation8

[back to top]

Number of Participants With Change/Improvement Visual Acuity From the Beseline

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)28
Methylprednisolone3
Observation5

[back to top]

MELD Score at 28 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 28 days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate22.57
Methylprednisolone20.95

[back to top]

MELD Score at 90 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 90 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.50
Methylprednisolone16.38

[back to top]

MELD Score at 180 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 180 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.81
Methylprednisolone11.85

[back to top]

180 Days Mortality

Death at 180 days (NCT01809132)
Timeframe: Time to event up to 6 months

InterventionParticipants (Count of Participants)
Anakinra & Pentoxifylline & Zinc Sulfate17
Methylprednisolone22
Observational0

[back to top]

Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac61.7
Vehicle43.0

[back to top]

Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac2.3
Vehicle17.3

[back to top]

Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac15.4
Vehicle27.3

[back to top]

Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01853072)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac76.2
Vehicle64.7

[back to top]

Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01853072)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac77.2
Vehicle67.7

[back to top]

Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac9.1
Vehicle15.3

[back to top]

Immunologic Graft Rejection Episode

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. (NCT01853696)
Timeframe: within first year after cornea transplantation

Interventioneyes (Number)
Loteprednol0
Prednisolone Acetate0

[back to top]

Intraocular Pressure

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. (NCT01853696)
Timeframe: from 1 to 12 months after transplant

Interventioneyes (Number)
Loteprednol11
Prednisolone Acetate27

[back to top]

Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac18.7
Vehicle16.7

[back to top]

Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac5.9
Vehicle14.3

[back to top]

Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01872611)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac65.4
Vehicle65.9

[back to top]

Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01872611)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac68.9
Vehicle62.1

[back to top]

Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac10.7
Vehicle8.9

[back to top]

Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac48.8
Vehicle50.5

[back to top]

To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD

To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.

,
InterventionParticipants (Count of Participants)
Day 28Day 56Day 180
Transplant Only000
Transplat Plus DLI110

[back to top]

To Assess the Proportions of GvHD Response Post-administration of AP1903.

To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903

InterventionParticipants (Count of Participants)
Day 3 post-administration of AP190371985950Day 3 post-administration of AP190371985951Day 7 post-administration of AP190371985951Day 7 post-administration of AP190371985950Day 14 post-administration of AP190371985951Day 14 post-administration of AP190371985950Day 28 post-administration of AP190371985951Day 28 post-administration of AP190371985950Day 56 post-administration of AP190371985951Day 56 post-administration of AP190371985950
no responsecomplete responseprogressionpartial response
Transplat Plus DLI1
Transplat Plus DLI0
Transplant Only0

[back to top]

To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.

,
InterventionParticipants (Count of Participants)
Day 3 post-administration of AP1903.Day 7 post-administration of AP1903.Day 14 post-administration of AP1903.Day 28 post-administration of AP1903.Day 56 post-administration of AP1903.
Transplant Only00000
Transplat Plus DLI11111

[back to top]

To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.

To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

[back to top]

To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.

To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

[back to top]

To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.

"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

[back to top]

To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism

To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

[back to top]

Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.

Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
disease-free survivaIchimerism post DLIGVHD post DLInon-relapse mortality
Transplant Only0000
Transplat Plus DLI1110

[back to top]

Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation

Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability). (NCT01977781)
Timeframe: 10 weeks

,
Interventionunits on a scale (Mean)
Ocular Burning SensationOcular DischargeOcular RednessOcular ItchingForeign Body Sensation
Methylprednisolone Sodium Succinate2.230.260.430.600.57
Tacrolimus3.500.161.250.500.70

[back to top]

Visual Acuity

Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range. (NCT01977781)
Timeframe: 10 weeks

InterventionLogMAR Scale (Mean)
Tacrolimus0.13
Methylprednisolone Sodium Succinate0.13

[back to top]

Tear Film Break-Up Time

Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time. (NCT01977781)
Timeframe: 10 weeks

InterventionSeconds (Mean)
Tacrolimus2.6
Methylprednisolone Sodium Succinate1.0

[back to top]

Schirmer Tear Test (mm)

Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeter (mm) (Mean)
Tacrolimus3.5
Methylprednisolone Sodium Succinate3.5

[back to top]

Ocular Surface Disease Index (OSDI) Questionnaire

The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus42
Methylprednisolone Sodium Succinate28

[back to top]

Intraocular Pressure

Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeters of mercury (mmHg) (Mean)
Tacrolimus16.5
Methylprednisolone Sodium Succinate17.1

[back to top]

Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)

Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus3.7
Methylprednisolone Sodium Succinate6.6

[back to top]

Health Assessment Questionnaire-Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Rituximab/Methylprednisolone/MTX1.911.05

[back to top]

Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
Rituximab/Methylprednisolone/MTX2.98

[back to top]

QALYS at 6 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection0.354
Wrist Splint0.356

[back to top]

QALYS at 24 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.461
Wrist Splint1.497

[back to top]

QALYS at 12 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection0.723
Wrist Splint0.736

[back to top]

NHS Cost Differences at 6 Months (CC)

Complete case analysis on the cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection353.48
Wrist Splint306.42

[back to top]

NHS Cost Differences at 6 Months

Cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection346.78
Wrist Splint313.24

[back to top]

NHS Cost Differences at 24 Months

Cost of interventions at 24 months (NCT02038452)
Timeframe: 24 months

InterventionUK Pounds (Mean)
Steroid Injection657.87
Wrist Splint586.77

[back to top]

NHS Cost Differences at 12 Months

Cost of interventions at 12 months (NCT02038452)
Timeframe: 12 months

InterventionUK Pounds (Mean)
Steroid Injection508.69
Wrist Splint395.54

[back to top]

Hand-wrist Pain Intensity Over 24 Months: 6 Weeks

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

[back to top]

Hand-wrist Pain Intensity Over 24 Months: 6 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

[back to top]

Hand-wrist Pain Intensity Over 24 Months: 24 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months. (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection2.81
Wrist Splint2.40

[back to top]

Hand-wrist Pain Intensity Over 24 Months: 12 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection3.17
Wrist Splint3.14

[back to top]

Hand-wrist Pain Intensity 6 Weeks (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.44

[back to top]

Hand-wrist Pain Intensity 6 Weeks (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

[back to top]

Hand-wrist Pain Intensity 6 Weeks

Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain). (NCT02038452)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Steroid Injection3.42
Wrist Splint4.28

[back to top]

Hand-wrist Pain Intensity 6 Months (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.38

[back to top]

Hand-wrist Pain Intensity 6 Months (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

[back to top]

BCTQ Functional Limitations Subscale 6 Months

Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.91
Wrist Splint1.89

[back to top]

BCTQ Functional Limitations Subscale 6 Months (CC)

Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.85
Wrist Splint1.88

[back to top]

BCTQ Functional Limitations Subscale 6 Months (PP)

Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.89
Wrist Splint1.84

[back to top]

BCTQ Functional Limitations Subscale 6 Weeks

Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.09

[back to top]

BCTQ Functional Limitations Subscale 6 Weeks (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.86
Wrist Splint2.10

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Months

Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.06

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Months (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Months (PP)

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.09
Wrist Splint2.02

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.29

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.96
Wrist Splint2.28

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)

Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)

Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.03
Wrist Splint2.26

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)

Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.40

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)

Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

[back to top]

BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)

Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.19

[back to top]

BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection1.98
Wrist Splint2.05

[back to top]

BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

[back to top]

Hand-wrist Pain Intensity 6 Months

Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain. (NCT02038452)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Steroid Injection4.32
Wrist Splint3.46

[back to top]

BCTQ Symptom Severity Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

[back to top]

BCTQ Symptom Severity Subscale 6 Weeks (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

[back to top]

BCTQ Symptom Severity Subscale 6 Weeks

Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.12
Wrist Splint2.43

[back to top]

BCTQ Symptom Severity Subscale 6 Months (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.28
Wrist Splint2.15

[back to top]

BCTQ Symptom Severity Subscale 6 Months (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.29
Wrist Splint2.16

[back to top]

BCTQ Symptom Severity Subscale 6 Months

Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.33
Wrist Splint2.18

[back to top]

BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.30

[back to top]

BCTQ Functional Limitations Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data.~BCTQ: Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.06

[back to top]

Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks

Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.02
Wrist Splint2.29

[back to top]

Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.79
Wrist Splint1.73

[back to top]

Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

[back to top]

Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

[back to top]

Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

[back to top]

Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)

Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2. (NCT02167217)
Timeframe: One year

Interventionunits on a scale (Mean)
Oral Prednisolone4.8

[back to top]

GVHD-free Survival Rate

Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method. (NCT02176031)
Timeframe: Day 56

Interventionpercentage of patients (Number)
Natalizumab33.3

[back to top]

Rate of GVHD Flares

Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab. (NCT02176031)
Timeframe: by Day 28

InterventionParticipants (Count of Participants)
Natalizumab0

[back to top]

GI aGVHD Response Rate

Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD. (NCT02176031)
Timeframe: Day 28, Day 56

Interventionpercentage of patients (Number)
Overall response rate for GI GVHD at Day 28Overall response rate for GI GVHD at Day 56
Natalizumab5752

[back to top]

Graft-verus-host Disease (GVHD) Response Rate

"Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD.~Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting.~Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ.~Non-response (NR) is defined as no reduction in any GVHD organ staging.~Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent.~Overall Response Rate (ORR) is the sum of CR, VGPR, and PR." (NCT02176031)
Timeframe: 28 Days, 56 Days

InterventionParticipants (Count of Participants)
Overall Response at Day 28Complete Response at Day 28Very Good Partial Response at Day 28Partial Response at Day 28Non-response/Progression of GVHD at Day 28Overall Response at Day 56Complete Response at Day 56Very Good Partial Response at Day 56Partial Response at Day 56Non-response/Progression of GVHD at Day 56
Natalizumab127237117226

[back to top]

Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.

Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab. (NCT02176031)
Timeframe: Day 28, 56, and 100

Interventionpercentage of steroid dose (Median)
Median reduction in steroid dose at day 28Median reduction in steroid dose at day 56Median reduction in steroid dose at day 100
Natalizumab427185

[back to top]

Overall Survival (OS) Rate

Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method. (NCT02176031)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Natalizumab43

[back to top] [back to top]

Number of Participants With Secondary Graft Failure

"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
Treatment0

[back to top]

Number of Participants With Overall Survival (OS)

"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment6

[back to top]

Number of Participants With Neutrophil Engraftment

Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant

InterventionParticipants (Count of Participants)
Treatment11

[back to top]

Number of Participants With Event-free Survival (EFS)

"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment4

[back to top] [back to top]

Number of Participants With Malignant Relapse

"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment7

[back to top]

Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Chronic GVHDMildModerateSevere
Treatment11001

[back to top]

Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Acute GVHDGrade IGrade IIGrade IIIGrade IV
Treatment80121

[back to top]

Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected. (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg1.0
Methylprednisolone, 40 mg1.8
Triamcinolone, 20 mg1.9
Triamcinolone, 40 mg1.8

[back to top]

Change in Shoulder Function, as Measured by the QuickDASH ®

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg19.2
Methylprednisolone, 40 mg21.3
Triamcinolone, 20 mg19.1
Triamcinolone, 40 mg24.7

[back to top]

Tear Break Up Time (TBUT)

TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. (NCT02256969)
Timeframe: 4 week Time Point

InterventionSeconds (Mean)
Meibomian Gland Probing Plus Lubricant3.5
Sham Meibomian Gland Probing Plus Lubricant4.2
Meibomian Gland Probing Plus Blephamide3.2

[back to top]

Ocular Surface Disease Index (OSDI)

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant38.7
Sham Meibomian Gland Probing Plus Lubricant36.9
Meibomian Gland Probing Plus Blephamide37.3

[back to top]

Symptom Assessment in Dry Eye (SANDE)

A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant49.1
Sham Meibomian Gland Probing Plus Lubricant50.2
Meibomian Gland Probing Plus Blephamide47.6

[back to top]

Corneal Fluorescein Staining (CFS)

Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant2.4
Sham Meibomian Gland Probing Plus Lubricant2.0
Meibomian Gland Probing Plus Blephamide1.4

[back to top]

Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)000
Rituximab/Cyclophosphamide/Belimumab (RCB)000

[back to top]

Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96

"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)31.335.740.0
Rituximab/Cyclophosphamide/Belimumab (RCB)6.311.830.8

[back to top]

Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96

"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)9.122.727.3
Rituximab/Cyclophosphamide/Belimumab (RCB)4.89.59.5

[back to top]

Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)46.760.053.3
Rituximab/Cyclophosphamide/Belimumab (RCB)55.073.771.4

[back to top]

Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96

"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)14.320.00.0
Rituximab/Cyclophosphamide/Belimumab (RCB)15.830.027.8

[back to top]

Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)23.835.033.3
Rituximab/Cyclophosphamide/Belimumab (RCB)30.042.142.9

[back to top]

Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)19.015.016.7
Rituximab/Cyclophosphamide/Belimumab (RCB)5.015.011.1

[back to top]

Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)57.155.061.1
Rituximab/Cyclophosphamide/Belimumab (RCB)30.030.027.8

[back to top]

Frequency of Specific Adverse Events of Interest By Participant, By Week 96

"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)06002
Rituximab/Cyclophosphamide/Belimumab (RCB)06000

[back to top]

Count of Participants: Frequency of Non-renal Flares by Week 96

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)1840
Rituximab/Cyclophosphamide/Belimumab (RCB)1911

[back to top]

Frequency of Specific Adverse Events of Interest By Event by Week 96

"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionEvents (Number)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)013003
Rituximab/Cyclophosphamide/Belimumab (RCB)016000

[back to top]

Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)18.245.563.6
Rituximab/Cyclophosphamide/Belimumab (RCB)14.328.647.6

[back to top]

Count of Participants: Frequency of Non-renal Flares by Week 24

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)2110
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

[back to top]

Count of Participants: Frequency of Non-renal Flares by Week 48

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flares2 Non-renal flare
Rituximab/Cyclophosphamide (RC)2020
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

[back to top]

Percentage of Participants With a Sustained Complete Response

"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96

Interventionpercentage of participants (Number)
Rituximab/Cyclophosphamide (RC)26.7
Rituximab/Cyclophosphamide/Belimumab (RCB)28.6

[back to top]

Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)

"MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.~The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5." (NCT02296346)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
EDSS ScoreMSFC Z-Score
Corticosteroid Arm6.250.6751
ECP Arm61.1031

[back to top]

Anterior Chamber Cell Grade at Week 8

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. (NCT02406209)
Timeframe: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Interventionunits on a scale (Least Squares Mean)
NS2 Ophthalmic Drops (0.5%)-0.7
NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops-0.9
Pred Forte® (1%) Ophthalmic Drops-0.5

[back to top]

Relapse Free Survival

Relapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first. (NCT02464657)
Timeframe: Up to 2 years and10 Months

InterventionMonths (Median)
Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine18.54

[back to top]

Event-Free Survival (EFS)

EFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. (NCT02464657)
Timeframe: 56 days

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + CytarabineNA

[back to top]

Maximum Tolerated Dose (MTD) of Nivolumab

MTD is highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). (NCT02464657)
Timeframe: 28 days

Interventionmg/kg (Number)
Ph 1 - Nivolumab (1mg) + Idarubicin + CytarabineNA
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine3

[back to top]

Overall Survival

Overall survival was defined as the time from the start of treatment to death or date of last follow-up. (NCT02464657)
Timeframe: Up to 2 years and 10 Months

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine18.54

[back to top]

Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign. (NCT02515045)
Timeframe: Month 1.

InterventionmmHg (Mean)
TriMoxiVanc-0.5
TriMoxiVanc + Ilevro-1.03
Control-1.1

[back to top]

Change From Baseline (Preoperative Exam) in Macular Thickness

Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease. (NCT02515045)
Timeframe: Month 1.

InterventionMicrons (Mean)
TriMoxiVanc12.34
TriMoxiVanc + Ilevro10.96
Control9.84

[back to top]

Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery." (NCT02515045)
Timeframe: Month 1

InterventionMicrons (Mean)
TriMoxiVanc14.44
TriMoxiVanc + Ilevro5.94
Control4.47

[back to top]

Degree of Dysphagia Patients Experience (Fear Swallow)

SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10093.7587.593.75100100100
Treatment100100100100100100100

[back to top]

Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain

Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control17.51056.455.824
Treatment195.356.452.752.51.1751

[back to top]

Degree of Dysphagia Patients Experience (Eating Duration)

SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100755087.5100100100
Treatment1007575100100100100

[back to top]

Patients' Pain Scores on the Visual Analog Scale - Neck Pain

Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control54.551.55120221412.25
Treatment2648.2526.514.59.566.5

[back to top]

Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain

Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control20237463.5
Treatment15.52.2542222.4

[back to top]

Patients' Bazaz Dysphagia Score - Liquid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323489Pre-operative72323488POD172323488POD172323489POD272323488POD2723234896-4 weeks723234886-4 weeks723234893 months723234883 months723234896 months723234896 months723234881 year723234881 year72323489
NoneRare
Control47
Treatment54
Control6
Treatment2
Control20
Treatment36
Control33
Treatment20
Control17
Treatment23
Control34
Treatment31
Treatment39
Control18
Treatment17
Control39
Control11
Treatment13
Control42
Treatment41
Control9
Treatment10
Control35
Treatment40
Control10
Treatment7

[back to top]

Patients' Bazaz Dysphagia Score - Solid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323488Pre-operative72323489POD172323488POD172323489POD272323488POD2723234896-4 weeks723234896-4 weeks723234883 months723234883 months723234896 months723234886 months723234891 year723234891 year72323488
RareOccasionally (only with specific food)NoneFrequent (majority of solids)
Control44
Treatment52
Treatment17
Control8
Control21
Treatment18
Control6
Treatment15
Treatment13
Control19
Control17
Treatment27
Control18
Treatment16
Control11
Treatment11
Treatment2
Control25
Treatment34
Treatment8
Control12
Control2
Treatment0
Control30
Treatment37
Control15
Treatment10
Control5
Treatment3
Control1
Treatment1
Control29
Treatment35
Control7
Treatment6
Control9
Treatment4
Control0

[back to top]

Degree of Dysphagia Patients Experience (Food Selection)

SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1007562.5100100100100
Treatment10093.7575100100100100

[back to top]

Degree of Dysphagia Patients Experience (Mental)

SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100808595100100100
Treatment10010097.5100100100100

[back to top]

Degree of Dysphagia Patients Experience (Sleep)

SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control7562.5505062.562.575
Treatment81.2556.2562.575757587.5

[back to top]

Degree of Dysphagia Patients Experience (Burden)

SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1005062.5100100100100
Treatment1007575100100100100

[back to top]

Degree of Dysphagia Patients Experience (Social)

SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1009585100100100100
Treatment100100100100100100100

[back to top]

Patient Reported Swallowing Difficulty Over 1 Year

"The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.~Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization.~Eat-10 interpretation: Score ranging from 0 to 40 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response" (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operative Eat-10Pre-operative Eat-10 modifiedPOD1 Eat-10POD1 Eat-10 modifiedPOD2 Eat-10POD2 Eat-10 modified4-6 weeks Eat-104-6 weeks Eat-10 modified3 months Eat-103 months Eat-10 modified6 months Eat-106 months Eat-10 modified1 year Eat-101 year Eat-10 modified
Control001614161454221100
Treatment0098.58722000000

[back to top]

Patients' Neck Disability

Neck Disability Index (NDI) Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionindex (Mean)
Pre-operative4-6 weeks3 months6 months1 year
Control35.535.327.323.920.6
Treatment29.930.817.715.413.2

[back to top]

Degree of Dysphagia Patients Experience (Eating Desire)

SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10083.383.3100100100100
Treatment10087.591.7100100100100

[back to top]

Degree of Dysphagia Patients Experience (Communication)

SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100100100100100100100
Treatment100100100100100100100

[back to top]

Adverse Event

"Adverse Event (AE) following surgical treatment.~Adverse event were classified by severity based on the AO-ISSG criteria and treatment required:~Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.~AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)" (NCT02539394)
Timeframe: 12 month

,
InterventionParticipants (Count of Participants)
Any Adverse Event?Mild/Moderate Adverse Event?Severe Adverse Event?Adverse Event Related to Operated Site?Adverse Event Unrelated to Operated Site?Mild/Moderate Adverse Event Related to Operated Site?Mild/Moderate Adverse Event Unrelated to Operated Site?Severe Adverse Event Related to Operated Site?Severe Adverse Event Unrelated to Operated Site?Adverse Event Potentially Related to Steroid Use?Adverse Event Unrelated to Steroid use?Mild/Moderate Adverse Event Potentially Related to Steroid Use?Mild/Moderate Adverse Event Unrelated to Steroid use?Severe Adverse Event Potentially Related to Steroid Use?Severe Adverse Event Unrelated to Steroid use?
Control444233826362630114394221
Treatment4746338303730301642154112

[back to top]

Fusion Rate

"Flex-Ex X-rays~Bony bridging on a CT scan~Obvious bony remodeling on lateral X-ray" (NCT02539394)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Treatment25
Control23

[back to top]

Degree of Dysphagia Patients Experience (Fatigue)

SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control83.3358.3358.3358.33757575
Treatment83.3358.3366.677583.3383.3391.67

[back to top]

Subjective Symptom Composite Scoring

"A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: blockage/congestion, runny nose, post-nasal discharge, facial pain/pressure, and sense of taste/smell. Range of 0 to 25, with higher score reflecting worse symptoms." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline16.311.9
Sugar Pill17.113.6

[back to top]

Visual Analog Scale

The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively. (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline8.45.2
Sugar Pill8.14.5

[back to top]

Endoscopic Nasal Polyp Score

"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline6.04.3
Sugar Pill6.54.9

[back to top]

Middle Meatus Culture

Culture swab for the presence or absence of microbial growth (NCT02569437)
Timeframe: Baseline and 12 weeks

,
InterventionParticipants (Count of Participants)
Culture growth at initial visit and 12 week visitCulture growth initial visit, none at 12 weeksNo growth initial visit, but growth at 12 weeks
Doxycycline512
Sugar Pill221

[back to top]

Sino-nasal Outcome Test (SNOT 22)

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline55.243.7
Sugar Pill54.449.8

[back to top]

Pain Scale Score

Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. (NCT02576249)
Timeframe: Pre-injection, immediately post-injection, 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
Pre-injection ActivityPre-injection RestImmediately Post-injection ActivityImmediately Post-injection Rest2 Weeks Activity2 Weeks Rest3 Months Activity3 Months Rest
Ropivacaine and Methylprednisolone6.42.41.91.23.61.73.92.6
Saline and Methylprednisolone5.842.41.43.62.74.62.8

[back to top]

Tegner Activity Level Scale

"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport." (NCT02576249)
Timeframe: baseline (pre-injection), 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
baseline (pre-injection)2 weeks3 months
Ropivacaine and Methylprednisolone3.54.33.5
Saline and Methylprednisolone3.03.23

[back to top]

The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. (NCT02576249)
Timeframe: 3 months after the injection

Interventionunits on a scale (Mean)
Ropivacaine and Methylprednisolone63.1
Saline and Methylprednisolone67.2

[back to top]

Palmar Pain Score

Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg86.4
Methylprednisolone 40 mg84.6
Placebo83.0

[back to top]

Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand

Number of patients who have had carpal tunnel release surgery on the study hand. (NCT02652390)
Timeframe: 5 to 7 years

InterventionParticipants (Count of Participants)
Methylprednisolone 80 mg31
Methylprednisolone 40 mg34
Placebo36

[back to top]

Bodily Pain Score

Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg81.4
Methylprednisolone 40 mg79.9
Placebo78.2

[back to top]

11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg13.1
Methylprednisolone 40 mg16.9
Placebo19.3

[back to top]

Symptom Severity Score

Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
80-mg Mrthylprednisolone and no Surgery1.34
Surgery After Methylprednisolone or Placebo1.53

[back to top]

Satisfaction Score

Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg77.5
Methylprednisolone 40 mg71.4
Placebo68.4

[back to top]

Core Body Temperature in Degrees Celcius.

Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours. (NCT02790788)
Timeframe: Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.

,
InterventionDegrees Celcius (Mean)
Temperature averaged over 0-6 hours after ROSCTemperature averaged over 6-12 hours after ROSCTemperature averaged over 12-18 hours after ROSCTemperature averaged over 18-24 hours after ROSCTemperature averaged over 24-30 hours after ROSCTemperature averaged over 30-36 hours after ROSCTemperature averaged over 36-42 hours after ROSCTemperature averaged over 42-48 hours after ROSC
Control Group35.636.636.536.336.236.236.236.3
Steroids Group36.536.336.036.136.136.036.136.2

[back to top]

Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group71.1
Control Group70.1

[back to top]

Organ Failure-free Days.

Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore <3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure. (NCT02790788)
Timeframe: Days 1 to 60 postrandomization.

InterventionNumber of Days without Organ Failure (Median)
Steroids Group0
Control Group0

[back to top]

Survival to Hospital Discharge With Favorable Functional Outcome.

Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death. (NCT02790788)
Timeframe: Up to 180 days postrandomization.

InterventionParticipants (Count of Participants)
Steroids Group2
Control Group5

[back to top]

Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.

Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 4 and 72 hours postresuscitation.

,
InterventionnM/s (Mean)
CBFI 4 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 4 HOURS POST-ROSC MEAN MAP=96.0 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP= 97.0 MMHG
Control Group3.33.53.43.8
Steroids Group4.04.24.34.9

[back to top]

Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).

Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture. (NCT02790788)
Timeframe: Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.

,
InterventionLog(10) transformed values of pg/mL (Mean)
IL-6 at 4 hours after ROSCTNFα at 4 hours after ROSCIL-1β at 4 hours after ROSCIL-8 at 4 hours after ROSCIL-10 at 4 hours after ROSCIL-6 at 24 hours after ROSCTNFα at 24 hours after ROSCIL-1β at 24 hours after ROSCIL-8 at 24 hours after ROSCIL-10 at 24 hours after ROSCIL-6 at 48 hours after ROSCTNFα at 48 hours after ROSCIL-1β at 48 hours after ROSCIL-8 at 48 hours after ROSCIL-10 at 48 hours after ROSCIL-6 at 72 hours after ROSCTNFα at 72 hours after ROSCIL-1β at 72 hours after ROSCIL-8 at 72 hours after ROSCIL-10 at 72 hours after ROSC
Control Group2.222.032.032.431.761.992.002.092.291.541.911.962.032.171.531.901.962.042.191.45
Steroids Group2.191.972.072.391.762.062.022.062.271.691.871.992.092.151.561.932.002.052.151.66

[back to top]

Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.6

[back to top]

Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group73.3
Control Group70.5

[back to top]

Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.

Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
Interventioncm^2 (Mean)
LVEDA within 12 hours after ROSCRVEDA within 12 hours after ROSCLVEDA at 72 hours after ROSCRVEDA at 72 hours after ROSC
Control Group22.813.018.512.6
Steroids Group23.112.123.114.5

[back to top]

Left and Right Ventricular Ejection Fraction (%) by Echocardiography.

Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionPercentage (Mean)
LVEF within 12 hours after ROSCRVEF within 12 hours after ROSCLVEF at 72 hours after ROSCRVEF at 72 hours after ROSC
Control Group45.942.75044.7
Steroids Group42.341.74542.8

[back to top]

Steroid-associated Complications.

Episodes of 1) Hyperglycemia (defined as Blood Glucose >200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration >150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection). (NCT02790788)
Timeframe: Up to 180 days postrandomization.

,
InterventionNumber of Episodes per Patient (Median)
No. of Episodes of HyperglycemiaNo. of Episodes of HypernatremiaNo. of Episodes of Infections
Control Group000
Steroids Group000

[back to top]

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group79.9
Control Group81.9

[back to top]

Eccentricity Index by Echocardiography.

"Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) longitudinal (or anteroposterior) diameter to the LV transverse (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC." (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionECCENTRICITY INDEX (Mean)
End-diastolic ECCI within 12 hours after ROSCEnd-systolic ECCI within 12 hours after ROSCEnd-diastolic ECCI at 72 hours after ROSCEnd-systolic ECCI at 72 hours after ROSC
Control Group1.31.31.31.3
Steroids Group1.21.31.21.2

[back to top]

Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.6
Control Group5.4

[back to top]

Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionPercent Hemoglobin Saturation (Mean)
Steroids Group72.5
Control Group70.4

[back to top]

Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).

Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group67.4
Control Group56.8

[back to top]

Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 48 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.7

[back to top]

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC). (NCT02790788)
Timeframe: Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

InterventionmmHg (Mean)
Steroids Group78.4
Control Group75.1

[back to top]

Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionL/min (Mean)
Steroids Group4.9
Control Group5.0

[back to top]

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group80.2
Control Group84.2

[back to top]

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group85.2
Control Group84.7

[back to top]

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group83.9
Control Group78.9

[back to top]

Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT02798523)
Timeframe: Up to 2 or 4 hours post infusion depending on group

InterventionParticipants (Count of Participants)
Up to 2 Hours Post Infusion5
Up to 4 Hours Post Infusion20

[back to top]

Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged76.5

[back to top]

Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged75.54

[back to top]

Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged74.52

[back to top]

Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months

Interventionpercentage of participants (Number)
KMT2A-Rearranged6.45

[back to top]

Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged78.17

[back to top]

Number of Participants With Sustained Headache Freedom

Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control10
Experimental6

[back to top]

Headache Days as Self-reported by Participants

At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

Interventiondays (Mean)
Control3.0
Experimental3.3

[back to top]

Medication Preference as Assessed by Self-report

"Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes." (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control76
Experimental75

[back to top]

Nonrelapse Mortality (NRM)

Defined as the proportion of subjects who died due to causes other than malignancy relapse. (NCT02953678)
Timeframe: From baseline to Months 6, 9, 12, and 24

Interventionpercentage of participants (Number)
6 months9 months12 months24 months
Ruxolitinib in Combination With Corticosteroids44.448.252.964.8

[back to top] [back to top]

Relapse Rate

Defined as the percentage of participants whose underlying malignancy relapsed. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids7.0

[back to top]

Percentage of Participants With Three-month DOR

Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. (NCT02953678)
Timeframe: From Baseline up to 3 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids84.5

[back to top]

Percentage of Participants With Six-month Duration of Response (DOR)

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. (NCT02953678)
Timeframe: From Baseline up to 6 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids68.2

[back to top]

Overall Survival (OS)

Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids232.0

[back to top]

Failure-free Survival (FFS)

Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids85.0

[back to top]

Overall Response Rate (ORR) at Day 28

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT02953678)
Timeframe: From baseline to Day 28

InterventionParticipants (Count of Participants)
Responders - CRResponders - VGPRResponders - PR
Ruxolitinib in Combination With Corticosteroids19713

[back to top]

Overall Response Rate (ORR)

Defined as the percentage of participants demonstrating a CR, VGPR, or PR. (NCT02953678)
Timeframe: From baseline to days 14, 56, and 100

Interventionpercentage of participants (Number)
Day 14Day 56Day 100
Ruxolitinib in Combination With Corticosteroids62.036.632.4

[back to top]

Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. (NCT02953678)
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsGrade 3 or Higher TEAEs
Ruxolitinib in Combination With Corticosteroids715969

[back to top]

Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event

Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD). (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180
GLASSIA0000

[back to top]

Incidence of Chronic Graft-versus-host Disease (GvHD)

Incidence of chronic GvHD at Days 180 and 365 was reported. (NCT02956122)
Timeframe: Days 180 and 365

InterventionParticipants (Number)
Day 180Day 365
GLASSIA00

[back to top]

Infection-related Mortality - Percentage of Participants With an Event

Infection-related mortality was determined by the investigator (any deaths considered related to infection [including infections related to hematopoietic stem cell transplant {HSCT}]). (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

[back to top] [back to top]

Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the date of randomization to the date of death due to any cause. (NCT02956122)
Timeframe: Days 100, 180 and 365

InterventionPercentage of participants (Number)
Day 100Day 180Day 365
GLASSIANANANA

[back to top] [back to top]

Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180

Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL. (NCT02956122)
Timeframe: Days 28, 56 and 180

InterventionParticipants (Count of Participants)
Day 28: Degree of skin Involvement72260019Day 28: Degree of GI Involvement72260019Day 28: Degree of liver Involvement72260019Day 56: Degree of skin Involvement72260019Day 56: Degree of GI Involvement72260019Day 56: Degree of liver Involvement72260019Day 180: Degree of skin Involvement72260019Day 180: Degree of GI Involvement72260019Day 180: Degree of liver Involvement72260019
Stage 1Stage 3Stage 4Stage 0Stage 2
GLASSIA1
GLASSIA0

[back to top]

Failure-free Survival - Percentage of Participants With an Event

Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy. (NCT02956122)
Timeframe: Days 100 and 180

InterventionPercentage of participants (Number)
Day 100Day 180
GLASSIA100100

[back to top]

All-cause Mortality - Percentage of Participants With an Event

All-cause mortality was defined as the time from HSCT to death due to any cause. (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

[back to top]

Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event

GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy. (NCT02956122)
Timeframe: Days 28, 56, 100, 180 and 365

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180Day 365
GLASSIA100100100100100

[back to top]

Systemic Clearance at Steady State (CLss) of GLASSIA

CLss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliters per hour (dL/h) (Number)
GLASSIA: Day 13: 30 mg/kg0.297
GLASSIA: Day 22: 120 mg/kg0.286
GLASSIA: Day 50: 120 mg/kg0.260

[back to top]

Percentage of Participants Achieving Overall Response at Day 56

Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 56

InterventionPercentage of participants (Number)
GLASSIA100

[back to top]

Percentage of Participants Achieving Overall Response (OR) At Day 28

OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

[back to top]

"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"

AUC(0-t) of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

Interventionh*mg/dL (Number)
GLASSIA: Day 1: 90 mg/kg16300
GLASSIA: Day 13: 30 mg/kg11000
GLASSIA: Day 22: 120 mg/kg40400
GLASSIA: Day 50: 120 mg/kg33400

[back to top]

Apparent Terminal Half-life (t1/2) of GLASSIA

Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionHour (h) (Number)
GLASSIA: Day 1: 90 mg/kg152
GLASSIA: Day 13: 30 mg/kg117
GLASSIA: Day 22: 120 mg/kg317
GLASSIA: Day 50: 120 mg/kg247

[back to top]

Apparent Volume of Distribution at Steady State (Vss) of GLASSIA

Vss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliter (dL) (Number)
GLASSIA: Day 13: 30 mg/kg50.9
GLASSIA: Day 22: 120 mg/kg123
GLASSIA: Day 50: 120 mg/kg91.1

[back to top]

Number of Participants With Recurrence of Primary Malignancies

Incidence of recurrence of primary malignancies was reported. (NCT02956122)
Timeframe: Baseline up to Day 365

InterventionParticipants (Count of Participants)
GLASSIA0

[back to top]

Number of Participants With Clinically Significant Changes in Vital Signs

Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

[back to top]

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

[back to top]

Maximum Observed Plasma Concentration (Cmax) of GLASSIA

Cmax of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionMilligrams per deciliter (mg/dl) (Number)
GLASSIA: Day 1: 90 mg/kg339
GLASSIA: Day 13: 30 mg/kg262
GLASSIA: Day 22: 120 mg/kg390
GLASSIA: Day 50: 120 mg/kg409

[back to top]

Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity

AUC of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours

InterventionHour*milligrams per deciliter (h*mg/dL) (Number)
GLASSIA: Day 1: 90 mg/kg61500
GLASSIA: Day 13: 30 mg/kg43500
GLASSIA: Day 22: 120 mg/kg126000
GLASSIA: Day 50: 120 mg/kg117000

[back to top]

Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28

GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

[back to top]

Number of Subjects With Adverse Events

Adverse events (NCT02962284)
Timeframe: one year

InterventionParticipants (Number)
Preceding Treatment - Yonsa8
Preceding Treatment - Zytiga9

[back to top]

Percentage of Subjects With Prostate Specific Antigen - 50 Response

A decrease of ≥50% reduction from baseline of the study CHL-AA-201 (NCT02962284)
Timeframe: 360 days

Interventionpercentage of number of subjects (Number)
Preceding Treatment - Yonsa60.0
Preceding Treatment - Zytiga55.6

[back to top]

Proportion of Subjects With Disease Progression

Number of participants who had disease progression (NCT02962284)
Timeframe: one year

InterventionParticipants (Count of Participants)
Preceding Treatment - Yonsa1
Preceding Treatment - Zytiga3

[back to top]

Prostate Specific Antigen Levels

Change in serum testosterone levels after one year of treatment against baseline (NCT02962284)
Timeframe: One year

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-60.12
Preceding Treatment - Zytiga-112.76

[back to top]

Testosterone Complete Suppression

Proportion of subjects with complete suppression of testosterone levels (NCT02962284)
Timeframe: 360 days

Interventionpercentage of subjects (Number)
Preceding Treatment - Yonsa100
Preceding Treatment - Zytiga87.5

[back to top]

Testosterone Levels

Change in serum testosterone levels from baseline (NCT02962284)
Timeframe: Baseline and 360 days

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-6.24
Preceding Treatment - Zytiga-5.87

[back to top]

Uncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.078
Prednisolone Acetate 1% Oph Susp-0.075

[back to top]

Number of Eyes With Corneal Haze

As determined by slit lamp examination (NCT03123614)
Timeframe: 12 months

InterventionEyes (Count of Units)
Loteprednol Etabonate 0.5% Oph Gel3
Prednisolone Acetate 1% Oph Susp7

[back to top]

Change in Intraocular Pressure (IOP) From Baseline Through Month 3

Intraocular pressure will be measured by applanation tonometry (NCT03123614)
Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

,
InterventionmmHg (Mean)
Baseline intraocular pressure (IOP)IOP 1 week postopIOP 1 month postopIOP 2 months postopIOP 3 months postop
Loteprednol Etabonate 0.5% Oph Gel14.3813.6714.1513.3613.15
Prednisolone Acetate 1% Oph Susp14.3013.2814.6013.1612.22

[back to top]

Best Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.120
Prednisolone Acetate 1% Oph Susp-0.114

[back to top]

Proportion of Subjects Who Discontinue Immunosuppressive Medications

Summary statistics of subjects discontinuing immunosuppressive medications will be calculated (NCT03139604)
Timeframe: Days 56 and 100

,
Interventionparticipants (Number)
Day 56Day 100
Itacitinib Plus Corticosteroids1211
Placebo Plus Corticosteroids108

[back to top]

Cmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as maximum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids796

[back to top]

AUC of Itacitinib When Administered in Combination With Corticosteroids

Defined as area under the concentration-time curve. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM*h (Mean)
Itacitinib Plus Corticosteroids6720

[back to top]

CL/F of Itacitinib When Administered in Combination With Corticosteroids

Defined as oral dose clearance. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionL/h (Mean)
Itacitinib Plus Corticosteroids104

[back to top]

Cmin of Itacitinib When Administered in Combination With Corticosteroids

Defined as minimum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids72.5

[back to top]

Duration of Response

Defined as the interval from first response until GVHD progression or death. (NCT03139604)
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids587
Placebo Plus CorticosteroidsNA

[back to top]

Failure-free Survival

Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) (NCT03139604)
Timeframe: 6 months from randomization

Interventionproportion of participants (Number)
Itacitinib Plus Corticosteroids44.29
Placebo Plus Corticosteroids40.00

[back to top]

Incidence Rate of aGVHD Flares

(NCT03139604)
Timeframe: up to day 100

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids42
Placebo Plus Corticosteroids48

[back to top]

Incidence Rate of Secondary Graft Failure

Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids2
Placebo Plus Corticosteroids0

[back to top] [back to top]

Number of Treatment-emergent Adverse Events With INCB39110

Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment (NCT03139604)
Timeframe: 30-35 days after end of treatment, approximately 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids208
Placebo Plus Corticosteroids214

[back to top]

Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT03139604)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Itacitinib Plus Corticosteroids74.0
Placebo Plus Corticosteroids66.4

[back to top]

Overall Survival (OS)

Defined as the interval from study enrollment to death due to any cause. (NCT03139604)
Timeframe: End of Study up to approximately 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids365
Placebo Plus Corticosteroids348.5

[back to top]

Relapse Rate of Malignant and Nonmalignant Hematologic Disease

Defined as the proportion of subjects whose underlying hematologic disease relapses (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionpercentage (Number)
Itacitinib Plus Corticosteroids12.4
Placebo Plus Corticosteroids11.4

[back to top]

Time to Response

Defined as the interval from treatment initiation to first response (NCT03139604)
Timeframe: End of Study, total particpation expected to average 24 months

Interventiondays (Mean)
Itacitinib Plus Corticosteroids9.9
Placebo Plus Corticosteroids10.1

[back to top]

Tmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as time to maximum plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

Interventionhrs (Median)
Itacitinib Plus Corticosteroids2.1

[back to top]

Incidence Rate of cGVHD

(NCT03139604)
Timeframe: Days 180 and 365

,
Interventionparticipants (Number)
Day 180Day 365
Itacitinib Plus Corticosteroids2543
Placebo Plus Corticosteroids3658

[back to top]

Nonrelapse Mortality

Defined as the percentage of participants who died due to causes other than malignancy relapse. (NCT03139604)
Timeframe: Month 6,9,12 and 24

,
Interventionparticipants (Number)
6 Months9 Months12 Months24 Months
Itacitinib Plus Corticosteroids36465156
Placebo Plus Corticosteroids37455252

[back to top]

Objective Response Rate

(NCT03139604)
Timeframe: Days 14, 56 and 100

,
Interventionparticipants (Number)
Day 14Day 56Day 100
Itacitinib Plus Corticosteroids17013892
Placebo Plus Corticosteroids16012496

[back to top]

Proportion of Subjects Who Discontinue Corticosteroids

Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated (NCT03139604)
Timeframe: Days 28, 56, 100, and 180

,
Interventionparticipants (Number)
Day 28Day 56Day 100Day 180
Itacitinib Plus Corticosteroids3163939
Placebo Plus Corticosteroids3114545

[back to top]

Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

(NCT03229538)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone Arm12
Placebo Arm17

[back to top]

Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories

The 7 highest global ranking categories range from 91 (postoperative length of hospital stay > 90 days) to 97 (operative mortality). (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm103
Placebo Arm122

[back to top]

Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm237
Placebo Arm264

[back to top]

Number of Participants With a Post-operative Length of Stay Greater Than 90 Days

Calculated as discharge date minus surgery date. (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm18
Placebo Arm29

[back to top]

Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm41
Placebo Arm51

[back to top]

Number of Participants With Post-operative Low Cardiac Output Syndrome

"Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable." (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm37

[back to top]

Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm24

[back to top]

Visual Analog Scale Scores at Each Time Point.

VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain. (NCT03232749)
Timeframe: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline VAS scorePost-injection VAS score2 Weeks VAS score1 Month VAS score2 Month VAS score3 Month VAS score6 Month VAS score
Symptomatic Primary Osteoarthritis of the Shoulder4.541.861.182.052.562.502.44

[back to top]

ASES Scores at Each Time Point

ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better). (NCT03232749)
Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline ASES score2 Week ASES score1 Month ASES scrore2 Month ASES score3 Month ASES score6 Month ASES score
Symptomatic Primary Osteoarthritis of the Shoulder48.5279.7273.8628.6071.7861.48

[back to top]

SST (Simple Shoulder Test) Scores at Each Time Point

SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better) (NCT03232749)
Timeframe: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Interventionscore on a scale (Mean)
Baseline SST Score2 Week SST Score1 Month SST Score2 Month SST Score3 Month SST Score6 Month SST Score
Symptomatic Primary Osteoarthritis of the Shoulder5.298.407.325.926.737.00

[back to top]

Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.2421.6171.592
PRT-2761 0.5%1.7231.9201.857
PRT-2761 0%1.9731.9912.036
PRT-2761 1%2.0562.1762.222

[back to top]

Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.5921.8331.917
PRT-2761 0.5%1.2821.4111.371
PRT-2761 0%1.9572.1812.164
PRT-2761 1%1.4911.5261.603

[back to top]

Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol0.7750.8080.833
PRT-2761 0.5%2.4312.3621.922
PRT-2761 0%2.5272.3661.929
PRT-2761 1%2.6112.6022.204

[back to top]

Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol1.2171.3581.258
PRT-2761 0.5%2.5732.6772.250
PRT-2761 0%2.6472.6292.190
PRT-2761 1%2.5002.5092.293

[back to top]

Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone4.32.24.14.13.3

[back to top]

Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone1.22.61.71.111.32.6211.32.821.1

[back to top] [back to top] [back to top] [back to top] [back to top] [back to top] [back to top] [back to top]

Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone2729273043

[back to top]

Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 1: Week 8 (Baseline): 110% RMTParticipants 1: Week 8 (Baseline): 120% RMTParticipants 1: Week 8 (Baseline): 130% RMTParticipants 1: Week 8 (Post-baseline): 110% RMTParticipants 1: Week 8 (Post-baseline): 120% RMTParticipants 1: Week 8 (Post-baseline): 130% RMTParticipants 3: Week 8 (Baseline): 110% RMTParticipants 3: Week 8 (Baseline): 120% RMTParticipants 3: Week 8 (Baseline): 130% RMTParticipants 3: Week 8 (Post-baseline): 110% RMTParticipants 3: Week 8 (Post-baseline): 120% RMTParticipants 3: Week 8 (Post-baseline): 130% RMT
D-aspartate + IFN Beta-1a + Methylprednisolone3010514239128154239511531103118

[back to top]

Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone82715218612121510481215

[back to top] [back to top] [back to top]

Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 6: Week 8 (Baseline): 110% RMTParticipants 6: Week 8 (Baseline): 120% RMTParticipants 6: Week 8 (Baseline): 130% RMTParticipants 6: Week 8 (Post-baseline): 110% RMTParticipants 6: Week 8 (Post-baseline): 120% RMTParticipants 6: Week 8 (Post-baseline): 130% RMTParticipants 7: Week 8 (Baseline): 110% RMTParticipants 7: Week 8 (Baseline): 120% RMTParticipants 7: Week 8 (Baseline): 130% RMTParticipants 7: Week 8 (Post-baseline): 110% RMTParticipants 7: Week 8 (Post-baseline): 120% RMTParticipants 7: Week 8 (Post-baseline): 130% RMT
Placebo + IFN Beta-1a + Methylprednisolone288311826911253314014930135138

[back to top] [back to top]

Total Complication Rate

any complications, 30 day morbidity (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone19
Dexamethasone19

[back to top]

Mortality

any cause mortality (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone0
Dexamethasone0

[back to top]

Hospital Stay

from operation to discharge (NCT03403517)
Timeframe: 3 months

Interventionhours (Median)
Methylprednisolone98
Dexamethasone102

[back to top]

Complications, Post-anesthesia Care Unit (PACU)

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria) (NCT03403517)
Timeframe: up to 24 hours

InterventionParticipants (Count of Participants)
Methylprednisolone51
Dexamethasone58

[back to top]

PACU Stay

from operation to discharge from PACU (NCT03403517)
Timeframe: up to 24 hours

Interventionminutes (Median)
Methylprednisolone203
Dexamethasone186

[back to top]

Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

Thickness of the cornea measured in microns, measured as the change from baseline (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops3.18
Standard of Care0.63

[back to top]

Change From Baseline (Preoperative Exam) in Macular Thickness

Thickness of the macula measured in microns, recorded as the change from baseline. (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops4.91
Standard of Care1.30

[back to top]

Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline (NCT03578276)
Timeframe: Month 1

InterventionmmHg (Mean)
LessDrops-0.33
Standard of Care-0.21

[back to top]

Survival of Treatment

Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year. (NCT03593902)
Timeframe: During Treatment and Post Treatment up to 1 year

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation9

[back to top]

Change in Skin Score by mRSS

Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51). (NCT03593902)
Timeframe: Pre Treatment and Post Treatment

Interventionunits on a scale (Mean)
Pre TreatmentPost Treatment
Hematopoietic Stem Cell Transplantation2516

[back to top]

Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. (NCT03704584)
Timeframe: Post injection day (1-7), 2 weeks and at 6 weeks post intervention

,
Interventionscore on a scale (Mean)
Post injection day 1Post injection day 2Post injection day 3Post injection day 4Post injection day 5Post injection day 6Post injection day 7
Control Group (Corticosteroid Alone)3.73.02.62.22.01.51.6
Treatment Group (Corticosteroid Injection Plus Lidocaine)3.72.21.71.11.00.690.58

[back to top]

10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. (NCT03704584)
Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeks

,
Interventionscore on a scale (Mean)
Pre-Injection: How painful do you think the injection will be?Pre-Injection: How painful do you think it will be 1-minute after the injection?Pre-Injection: How nervous are you about the injection?Post-Injection: Actual pain of the needlePost-Injection: Actual pain of the medicationPost-Injection: Actual pain 1-minute after the injection
Control Group (Corticosteroid Alone)5.43.23.54.24.31.7
Treatment Group (Corticosteroid Injection Plus Lidocaine)5.94.44.04.34.71.7

[back to top]

Number of Patients With Subsequent Reinjection and Surgical Operation

The number of patients with subsequent reinjection and surgical operation was collected during follow up. (NCT03704584)
Timeframe: End of follow up (6 weeks post intervention)

InterventionParticipants (Count of Participants)
Treatment Group (Corticosteroid Injection Plus Lidocaine)0
Control Group (Corticosteroid Alone)0

[back to top]

Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). (NCT03797872)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Standard Care0

[back to top]

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Total Score

The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The KOOS has 42 items across all subscales and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. The sum of subscale scores is transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Mean)
Change from Baseline at Month 1Change from Baseline at Month 3Change from Baseline at Month 6Change from Baseline at Month 9Change from Baseline at Month 12
Adipose-derived MSCs14.3416.3017.5313.3617.61
Bone Marrow Derived MSCs14.4818.6318.3914.1718.52
Corticosteroid Injection17.7017.2117.44116.3019.27
Umbilical Cord Tissue (UCT) MSCs11.1413.8515.6213.9617.49

[back to top]

Change in Visual Analog Pain Scale (VAS-pain) Score

"Pain assessment was performed using the Visual Analog Pain Scale (VAS-pain). The VAS-pain is self-completed by the participant. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance in millimeters (mm) on the line between the no pain anchor and the participant's mark, providing a range of scores from 0-100. The recommended cut points for VAS are: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The change in VAS-pain score is the score from the each follow-up visit subtracted from the baseline score. A negative value means that pain has reduced from what it was at baseline." (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionunits on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs-15.9-17.8-21.6-17.9-19.9
Bone Marrow Derived MSCs-20.2-28.8-23.2-21.9-25.5
Corticosteroid Injection-25.2-21.1-22.7-23.3-22.3
Umbilical Cord Tissue (UCT) MSCs-16.7-17.3-19.7-16.5-20.6

[back to top]

Change in EuroQuality of Life (EQ-5D-3L) Index Score

"The EQ-5D-3L survey measures the severity of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3 (1 being no problem and 3 being most extreme problem). A sixth item asks participants to rate their current heath from 0 (worst imaginable) to 100 (best imaginable). The answers to these questions are converted into an index value based on the country respondents live in. Health state index scores typically range from less than 0 to 1, where 0 is a health state equivalent to death and 1 is perfect health. Positive values for the change from baseline score indicate improved health." (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs0.10.10.10.10.1
Bone Marrow Derived MSCs0.10.10.10.00.1
Corticosteroid Injection0.10.10.10.10.1
Umbilical Cord Tissue (UCT) MSCs0.10.10.10.10.1

[back to top]

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Subscale Score

The KOOS questionnaire assesses the participant's opinion about their osteoarthritis and associated problems. It consists of 5 subscales: pain, symptoms, activities of daily living (ADL) function, sport and recreation function, and knee related quality of life (QoL). The pain subscale has 9 items and response options are given on a 5-point Likert scale where 0 = no problems and 4 = extreme problems. Scores are transformed to a scale ranging from 0 to 100 with 0 indicating extreme symptoms and 100 indicating no symptoms. The change in KOOS-pain subscale score is the score from each follow-up visit subtracted from the baseline score. A negative value means that pain has worsened from what it was at baseline, while a positive value means that pain has improved from baseline. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventionscore on a scale (Least Squares Mean)
Absolute Change from Baseline at Month 1Absolute Change from Baseline at Month 3Absolute Change from Baseline at Month 6Absolute Change from Baseline at Month 9Absolute Change from Baseline at Month 12
Adipose-derived MSCs15.416.817.214.717.3
Bone Marrow Derived MSCs15.519.218.116.218.9
Corticosteroid Injection19.218.718.616.318.5
Umbilical Cord Tissue (UCT) MSCs11.512.815.413.916.4

[back to top]

Overall MRI Grade of Osteoarthritis

An MRI grade of osteoarthritis was calculated by rating features viewed by MRI (such as cartilage loss) in terms of severity and extent. Total scores range from 0 to 69 with higher values indicating more severe osteoarthritis. (NCT03818737)
Timeframe: Baseline, Month 6, Month 12

,,,
Interventionscore on a scale (Mean)
BaselineMonth 6Month 12
Adipose-derived MSCs39.739.339.8
Bone Marrow Derived MSCs40.540.440.8
Corticosteroid Injection38.939.339.0
Umbilical Cord Tissue (UCT) MSCs38.238.337.6

[back to top]

Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales are scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Scores higher than 50 indicate more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. (NCT03818737)
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

,,,
Interventiont-score (Mean)
Anxiety Score - BaselineAnxiety Score - Month 1Anxiety Score - Month 3Anxiety Score - Month 6Anxiety Score - Month 9Anxiety Score - Month 12Depression Score - BaselineDepression Score - Month 1Depression Score - Month 3Depression Score - Month 6Depression Score - Month 9Depression Score - Month 12Fatigue Score - BaselineFatigue Score - Month 1Fatigue Score - Month 3Fatigue Score - Month 6Fatigue Score - Month 9Fatigue Score - Month 12Pain Score - BaselinePain Score - Month 1Pain Score - Month 3Pain Score - Month 6Pain Score - Month 9Pain Score - Month 12Physical Function Score - BaselinePhysical Function Score - Month 1Physical Function Score - Month 3Physical Function Score - Month 6Physical Function Score - Month 9Physical Function Score - Month 12Sleep Disturbance Score - BaselineSleep Disturbance Score - Month 1Sleep Disturbance Score - Month 3Sleep Disturbance Score - Month 6Sleep Disturbance Score - Month 9Sleep Disturbance Score - Month 12Social Roles and Activities Score - BaselineSocial Roles and Activities Score - Month 1Social Roles and Activities Score - Month 3Social Roles and Activities Score - Month 6Social Roles and Activities Score - Month 9Social Roles and Activities Score - Month 12
Adipose-derived MSCs47.545.445.445.845.445.345.043.844.044.945.243.947.045.845.346.146.145.258.652.552.151.552.350.840.343.644.345.244.645.249.748.448.348.948.549.047.951.653.352.752.653.5
Bone Marrow Derived MSCs47.145.945.145.946.145.644.744.343.843.945.644.546.845.845.045.946.745.659.153.651.651.552.451.539.343.044.944.543.044.448.947.247.348.648.947.849.552.154.453.153.653.3
Corticosteroid Injection48.245.445.545.345.145.245.645.044644.044.144.548.546.244.845.146.845.360.453.353.553.653.252.738.343.342.943.043.043.650.249.247.948.947.948.846.951.551.652.052.452.2
Umbilical Cord Tissue (UCT) MSCs47.145.945.445.244.944.944.944.944.444.043.444.347.746.946.044.947.145.958.954.852.551.951.851.238.841.943.844.244.444.850.148.347.848.148.948.748.251.052.452.352.853.6

[back to top]

Oxygen-free Days

Number of days subjects did not require oxygen assistance. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Interventiondays (Median)
Usual Care21.0
Biomarker-adjusted Steroid Dosing24.0

[back to top]

Cardiovascular Dysfunction

Number of subjects with new and/or worsening right ventricle (RV)/left ventricle (LV) dysfunction (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

[back to top]

Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group) (NCT03852537)
Timeframe: Within 30 days of enrollment in study.

InterventionParticipants (Count of Participants)
Usual Care20
Biomarker-adjusted Steroid Dosing19

[back to top]

Organ Failure

Organ failures measured by Sequential Organ Failure Assessment (SOFA). The overall score is based on 6 sub-scores respiratory system, neurologic system, cardiovascular system, hepatic system, coagulation, and renal system using an overall scale of 0-24, which 0=no organ failure, 24=complete organ failure. (NCT03852537)
Timeframe: Measured daily for approximately 5 days

,
Interventionscore on a scale (Median)
Day 1Day 2Day 3Day 4Day 5
Biomarker-adjusted Steroid Dosing7.03.03.03.05.5
Usual Care3.03.03.03.03.0

[back to top]

ICU Admission

Number of subjects admitted to the ICU (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care10
Biomarker-adjusted Steroid Dosing5

[back to top]

Mortality

Number of subject deaths (NCT03852537)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

[back to top]

Myocardial Injury

Number of participants with evidence of myocardial injury determined by daily troponin peak and /or new diagnosis of Left Ventricular (LV) dysfunction (LVEF <40%) or new diagnosis of cor pulmonale (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care8
Biomarker-adjusted Steroid Dosing10

[back to top]

Need for High Flow Nasal Cannula Oxygen

Number of subjects to need high flow nasal cannula oxygen (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care7
Biomarker-adjusted Steroid Dosing4

[back to top]

Need for Invasive Mechanical Ventilation

Assessed by the number of participants that required invasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care3
Biomarker-adjusted Steroid Dosing2

[back to top]

Need for Noninvasive Mechanical Ventilation

Assessed by the number of participants that required noninvasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care4
Biomarker-adjusted Steroid Dosing2

[back to top]

New Onset Cardiac Arrhythmias

Number of participants who develop arrhythmias identified by electrocardiogram or echocardiogram. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing1

[back to top]

Occurrence of Delirium

Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care5
Biomarker-adjusted Steroid Dosing5

[back to top]

Occurrence of Hyperglycemia

Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care11
Biomarker-adjusted Steroid Dosing18

[back to top]

Occurrence of Secondary Infection

Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued. (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing0

[back to top]

Percentage of Participants With Antibody-Mediated Rejection

The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492010.010.015.0

[back to top]

Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

[back to top]

Percentage of Participants With Treated Acute Rejections

Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.030.0

[back to top]

Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

[back to top]

Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Belatacept+VIB492025.0

[back to top]

Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

[back to top]

Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Weeks 12 and 48

Interventionpercentage of participants (Number)
Week 12Week 48
Belatacept+VIB492025.025.0

[back to top]

Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) (NCT04184999)
Timeframe: 3 weeks

InterventionmOsmol/L (Mean)
Intracameral Dexamethasone311.15
Postoperative Prednisolone Acetate316.3

[back to top]

Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT04233164)
Timeframe: 2 hours and 4 hours post infusion

,
InterventionParticipants (Count of Participants)
2 hours post infusion4 hours post infusion
Group A: Glucocorticoids 1 mg/kg Dose2020
Group B: Glucocorticoids 250 mg Dose2020

[back to top]

Admission to Intensive Care Unit (ICU)

We reported below the number of participants admitted to ICU within 28 days. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone27

[back to top]

Change in C-reactive Protein (CRP)

Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement. (NCT04323592)
Timeframe: 7 days

Interventionmg/L (Mean)
Exposed to Methylprednisolone-82.08
Non-exposed to Methylprednisolone-34.34

[back to top]

Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone19
Non-exposed to Methylprednisolone40

[back to top]

Endotracheal Intubation (Invasive Mechanical Ventilation)

We reported below the number of participants who needed endotracheal intubation during ICU admission (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone26

[back to top]

Number of Days Free From Mechanical Ventilation

number of days free from mechanical ventilation (both invasive and non-invasive) by day 28 (NCT04323592)
Timeframe: 28 days

Interventiondays (Mean)
Exposed to Methylprednisolone19.11
Non-exposed to Methylprednisolone14.34

[back to top]

In-hospital Death Within 28 Days

We reported below the number of participants who died within 28 days, during the hospital stay. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone6
Non-exposed to Methylprednisolone21

[back to top]

Loss of Lines in Uncorrected Visual Acuity

All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. (NCT04380857)
Timeframe: Baseline to Day 7, Day 30 and Day 90

,
InterventionlogMAR (Mean)
1 week1 month3 months
Dexamethasone Ophthalmic Insert 0.4 mg-0.010-0.014-0.071
Topical Prednisolone Acetate Ophthalmic Drops0.013-0.026-0.068

[back to top]

Mean Change in Pain

"post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine)" (NCT04380857)
Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

,
InterventionScore on a scale from 0-10 (Mean)
Pre-operativeDay 1Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg0.150.950.470.410
Topical Prednisolone Acetate Ophthalmic Drops0.200.900.370.060

[back to top]

Patient Preference Between Groups

As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. (NCT04380857)
Timeframe: Day 7, Day 30 and Day 90

,,
InterventionParticipants (Count of Participants)
Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg14119
No Preference435
Topical Prednisolone Acetate Ophthalmic Drops233

[back to top]

Number of Lines Lost From Best Corrected Visual Acuity

After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 (NCT04380857)
Timeframe: Baseline through Day 90

InterventionScore on a scale (Mean)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

[back to top]

Post op Pain Management Per Eye

Count of participants requiring pain management from Day 0 to Day 90. (NCT04380857)
Timeframe: Day 0 to Day 90

InterventionEyes (Count of Units)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

[back to top]

Incidence of Pain

Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Betamethasone6
Methylprednisolone11

[back to top]

Intensity of Pain

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

,
Interventionscore on a scale (Mean)
BaselineFive MinutesDay 1Day 2Day 3Day 4Day 5Day 6Day 7
Betamethasone2.80.31.41.31.00.70.60.60.5
Methylprednisolone2.10.82.92.11.51.00.80.70.6

[back to top]

Number of Participants With Complications Following Treatment

Manipulations under anesthesia (MUAs) following total knee arthroplasty surgery and treatment (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper89.5

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper5.25

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.28

[back to top]

Adverse Events or Outcomes Outside of Manipulations Under Anesthesia

Adverse outcomes including infection, avascular necrosis, and 90-day readmission rates (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper72.12

[back to top]

Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)

"Using daily defense and veterans pain rating scale (DVPRS) on a scale of 1 to 10, 10 being the worst.~Please note, only one patient made it to the 6 week post treatment mark of the 4 enrolled. The study was terminated and none of the patients were randomized to the placebo group. All other patients followed up but were not interested in continuing. No range could be provided given only one subject answered and completed this visit" (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper1.93

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper57.82

[back to top]

Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. This is a standard of care survey available on all subjects." (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper78.75

[back to top]

Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group." (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper66.25

[back to top]

Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. At 3 weeks post treatment, only 3 of the 4 subjects enrolled were still part of the study." (NCT05113901)
Timeframe: 3 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper68.33

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper4.25

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper91.67

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.04

[back to top]

Range of Motion in Degrees at Pre and Post Treatment

"Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic.~This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care." (NCT05113901)
Timeframe: Baseline, Week 6 Following Treatment

InterventionRange of Motion in Degrees (Mean)
Pre treatmentPost treatment
Methylprednisolone Taper82.5112

[back to top]

Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores

"Using Daily Visual Analogue Scale (VAS) pain score, which measures intensity of pain on a scale of 0 (no pain) to 10 (worst pain possible).~**Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group." (NCT05113901)
Timeframe: Days 1 through 6 following treatment

Interventionscore on a scale (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6
Methylprednisolone Taper2.3331.331.331.672.3

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper29.5

[back to top]

Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Veterans Rand 12-Item Health Survey (VR-12), a survey of 12 questions to measure health relating to patient's quality of life. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper38.73

[back to top]

Incidence of a Flare Reaction

A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain. (NCT05438277)
Timeframe: Post-injection day 1 through 7

,
InterventionPerson-visits (Count of Units)
Flare reaction (Yes)Flare reaction (No)Unknown
Methylprednisolone Acetate (MPA)4414916
Triamcinolone Acetonide (TA)819128

[back to top]
SubstanceRelationship StrengthStudiesTrialsClassesRoles
benzyl alcohol
Benzyl Alcohol: A colorless liquid with a sharp burning taste and slight odor. It is used as a local anesthetic and to reduce pain associated with LIDOCAINE injection. Also, it is used in the manufacture of other benzyl compounds, as a pharmaceutic aid, and in perfumery and flavoring.. hydroxytoluene : Any member of the class of toluenes carrying one or more hydroxy substituents.. benzyl alcohol : An aromatic alcohol that consists of benzene bearing a single hydroxymethyl substituent.. aromatic alcohol : Any alcohol in which the alcoholic hydroxy group is attached to a carbon which is itself bonded to an aromatic ring.. aromatic primary alcohol : Any primary alcohol in which the alcoholic hydroxy group is attached to a carbon which is itself bonded to an aromatic ring.		8.0810benzyl alcoholsantioxidant;
fragrance;
metabolite;
solvent
chlorine
chloride : A halide anion formed when chlorine picks up an electron to form an an anion.		2.3920halide anion;
monoatomic chlorine		cofactor;
Escherichia coli metabolite;
human metabolite
bupropion
Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring.		2.0110aromatic ketone;
monochlorobenzenes;
secondary amino compound		antidepressant;
environmental contaminant;
xenobiotic
lactic acid
Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed). 2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group.		2.1102-hydroxy monocarboxylic acidalgal metabolite;
Daphnia magna metabolite
glycerol
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.		2.4120alditol;
triol		algal metabolite;
detergent;
Escherichia coli metabolite;
geroprotector;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
solvent
thioctic acid
Thioctic Acid: An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS.		2.5520dithiolanes;
heterocyclic fatty acid;
thia fatty acid		fundamental metabolite;
geroprotector
phenytoin
[no description available]		2.0510imidazolidine-2,4-dioneanticonvulsant;
drug allergen;
sodium channel blocker;
teratogenic agent
acemetacin
acemetacin : A carboxylic ester that is the carboxymethyl ester of indometacin. A non-steroidal anti-inflammatory drug, it is used in the treatment of rheumatoid arthritis, osteoarthritis, and low back pain, as well as for postoperative pain and inflammation. Its activity is due to both acemetacin and its major metabolite, indometacin.		3.3911carboxylic ester;
indol-3-yl carboxylic acid;
monocarboxylic acid;
monochlorobenzenes;
N-acylindole		EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
prodrug
acetaminophen
Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.		3.7721acetamides;
phenols		antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
cyclooxygenase 3 inhibitor;
environmental contaminant;
ferroptosis inducer;
geroprotector;
hepatotoxic agent;
human blood serum metabolite;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
diatrizoic acid
Diatrizoate: A commonly used x-ray contrast medium. As DIATRIZOATE MEGLUMINE and as Diatrizoate sodium, it is used for gastrointestinal studies, angiography, and urography.. amidotrizoic acid : A member of the class of benzoic acids that is benzoic acid having iodo substituents at the 2-, 4- and 6-positions and acetamido substituents at the 3- and 5-positions. It is used, mainly as its N-methylglucamine and sodium salts, as an X-ray contrast medium in gastrointestinal studies, angiography, and urography.		3.5120acetamides;
benzoic acids;
organoiodine compound		environmental contaminant;
radioopaque medium;
xenobiotic
aspirin
Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.		8.3511benzoic acids;
phenyl acetates;
salicylates		anticoagulant;
antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
EC 1.1.1.188 (prostaglandin-F synthase) inhibitor;
geroprotector;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
plant activator;
platelet aggregation inhibitor;
prostaglandin antagonist;
teratogenic agent
azathioprine
Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed). azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS.		2.6730aryl sulfide;
C-nitro compound;
imidazoles;
thiopurine		antimetabolite;
antineoplastic agent;
carcinogenic agent;
DNA synthesis inhibitor;
hepatotoxic agent;
immunosuppressive agent;
prodrug
berberine
[no description available]		1.9610alkaloid antibiotic;
berberine alkaloid;
botanical anti-fungal agent;
organic heteropentacyclic compound		antilipemic drug;
antineoplastic agent;
antioxidant;
EC 1.1.1.141 [15-hydroxyprostaglandin dehydrogenase (NAD(+))] inhibitor;
EC 1.1.1.21 (aldehyde reductase) inhibitor;
EC 1.13.11.52 (indoleamine 2,3-dioxygenase) inhibitor;
EC 1.21.3.3 (reticuline oxidase) inhibitor;
EC 2.1.1.116 [3'-hydroxy-N-methyl-(S)-coclaurine 4'-O-methyltransferase] inhibitor;
EC 2.1.1.122 [(S)-tetrahydroprotoberberine N-methyltransferase] inhibitor;
EC 2.7.11.10 (IkappaB kinase) inhibitor;
EC 3.1.1.4 (phospholipase A2) inhibitor;
EC 3.1.1.7 (acetylcholinesterase) inhibitor;
EC 3.1.1.8 (cholinesterase) inhibitor;
EC 3.1.3.48 (protein-tyrosine-phosphatase) inhibitor;
EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
geroprotector;
hypoglycemic agent;
metabolite;
potassium channel blocker
bufexamac
Bufexamac: A benzeneacetamide with anti-inflammatory, analgesic, and antipyretic action. It is administered topically, orally, or rectally.. bufexamac : A hydroxamic acid derived from phenylacetamide in which the benzene moiety is substituted at C-4 by a butoxy group. It has anti-inflammatory, analgesic, and antipyretic properties.		8.3511aromatic ether;
hydroxamic acid		antipyretic;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug
bupivacaine
Bupivacaine: A widely used local anesthetic agent.. 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide : A piperidinecarboxamide obtained by formal condensation of the carboxy group of N-butylpipecolic acid with the amino group of 2,6-dimethylaniline.. bupivacaine : A racemate composed of equimolar amounts of dextrobupivacaine and levobupivacaine. Used (in the form of its hydrochloride hydrate) as a local anaesthetic.		11.853916aromatic amide;
piperidinecarboxamide;
tertiary amino compound
cefuroxime
Cefuroxime: Broad-spectrum cephalosporin antibiotic resistant to beta-lactamase. It has been proposed for infections with gram-negative and gram-positive organisms, GONORRHEA, and HAEMOPHILUS.. cefuroxime : A 3-(carbamoyloxymethyl)cephalosporin compound having a 7-(2Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido side chain.		2.0110carbamate ester;
cephalosporin
cetirizine
Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively.		2.0110ether;
monocarboxylic acid;
monochlorobenzenes;
piperazines		anti-allergic agent;
environmental contaminant;
H1-receptor antagonist;
xenobiotic
diclofenac
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.		4.1131amino acid;
aromatic amine;
dichlorobenzene;
monocarboxylic acid;
secondary amino compound		antipyretic;
drug allergen;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
etidronate
Etidronic Acid: A diphosphonate which affects calcium metabolism. It inhibits ectopic calcification and slows down bone resorption and bone turnover.. etidronic acid : A 1,1-bis(phosphonic acid) that is (ethane-1,1-diyl)bis(phosphonic acid) having a hydroxy substituent at the 1-position. It inhibits the formation, growth, and dissolution of hydroxyapatite crystals by chemisorption to calcium phosphate surfaces.		2.04101,1-bis(phosphonic acid)antineoplastic agent;
bone density conservation agent;
chelator
fexofenadine
fexofenadine: a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; structure in first source; RN refers to HCl. fexofenadine : A piperidine-based anti-histamine compound.		2.0110piperidines;
tertiary amine		anti-allergic agent;
H1-receptor antagonist
furosemide
Furosemide: A benzoic-sulfonamide-furan. It is a diuretic with fast onset and short duration that is used for EDEMA and chronic RENAL INSUFFICIENCY.. furosemide : A chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively. It is a diuretic used in the treatment of congestive heart failure.		2.0510chlorobenzoic acid;
furans;
sulfonamide		environmental contaminant;
loop diuretic;
xenobiotic
gabapentin
Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.. gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome.		3.1710gamma-amino acidanticonvulsant;
calcium channel blocker;
environmental contaminant;
xenobiotic
gentamicin
Gentamicins: A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.		3.4211
ibuprofen
Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine		9.6132monocarboxylic acidantipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
environmental contaminant;
geroprotector;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
radical scavenger;
xenobiotic
lidocaine
Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline.		11.713711benzenes;
monocarboxylic acid amide;
tertiary amino compound		anti-arrhythmia drug;
drug allergen;
environmental contaminant;
local anaesthetic;
xenobiotic
indomethacin
Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis.		3.7921aromatic ether;
indole-3-acetic acids;
monochlorobenzenes;
N-acylindole		analgesic;
drug metabolite;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
environmental contaminant;
gout suppressant;
non-steroidal anti-inflammatory drug;
xenobiotic metabolite;
xenobiotic
iohexol
Iohexol: An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.. iohexol : A benzenedicarboxamide compound having N-(2,3-dihydroxypropyl)carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and an N-(2,3-dihydroxypropyl)acetamido group at the 5-position.		2.0310benzenedicarboxamide;
organoiodine compound		environmental contaminant;
radioopaque medium;
xenobiotic
ketorolac
Ketorolac: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is an NSAID and is used principally for its analgesic activity. (From Martindale The Extra Pharmacopoeia, 31st ed). ketorolac : A racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure.. 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : A member of the class of pyrrolizines that is 2,3-dihydro-1H-pyrrolizine which is substituted at positions 1 and 5 by carboxy and benzoyl groups, respectively.		2.610amino acid;
aromatic ketone;
monocarboxylic acid;
pyrrolizines;
racemate		analgesic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
non-steroidal anti-inflammatory drug
ketotifen
Ketotifen: A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.. ketotifen : An organic heterotricyclic compound that is 4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one which is substituted at position 4 by a 1-methylpiperidin-4-ylidene group. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is used (usually as its hydrogen fumarate salt) for the treatment of asthma, where it may take several weeks to exert its full effect.		2.0510cyclic ketone;
olefinic compound;
organic heterotricyclic compound;
organosulfur heterocyclic compound;
piperidines;
tertiary amino compound		anti-asthmatic drug;
H1-receptor antagonist
khellin
Khellin: A vasodilator that also has bronchodilatory action. It has been employed in the treatment of angina pectoris, in the treatment of asthma, and in conjunction with ultraviolet light A, has been tried in the treatment of vitiligo. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1024). khellin : A furanochrome in which the basic tricyclic skeleton is substituted at positions 4 and 9 with methoxy groups and at position 7 with a methyl group. A major constituent of the plant Ammi visnaga it is a herbal folk medicine used for various illnesses, its main effect being as a vasodilator.		210furanochromone;
organic heterotricyclic compound;
oxacycle		anti-asthmatic agent;
bronchodilator agent;
cardiovascular drug;
vasodilator agent
lansoprazole
Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.		2.0110benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
leflunomide
Leflunomide: An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.. leflunomide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-methyl-1,2-oxazole-4-carboxylic acid with the anilino group of 4-(trifluoromethyl)aniline. The prodrug of teriflunomide.		2.4220(trifluoromethyl)benzenes;
isoxazoles;
monocarboxylic acid amide		antineoplastic agent;
antiparasitic agent;
EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor;
EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor;
hepatotoxic agent;
immunosuppressive agent;
non-steroidal anti-inflammatory drug;
prodrug;
pyrimidine synthesis inhibitor;
tyrosine kinase inhibitor
mepivacaine
Mepivacaine: A local anesthetic that is chemically related to BUPIVACAINE but pharmacologically related to LIDOCAINE. It is indicated for infiltration, nerve block, and epidural anesthesia. Mepivacaine is effective topically only in large doses and therefore should not be used by this route. (From AMA Drug Evaluations, 1994, p168). mepivacaine : A piperidinecarboxamide in which N-methylpipecolic acid and 2,6-dimethylaniline have combined to form the amide bond. It is used as a local amide-type anaesthetic.		2.520piperidinecarboxamidedrug allergen;
local anaesthetic
methylphenidate
Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group.		2.8540beta-amino acid ester;
methyl ester;
piperidines
nitroglycerin
Nitroglycerin: A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.. nitroglycerol : A nitrate ester that is glycerol in which nitro group(s) replace the hydrogen(s) attached to one or more of the hydroxy groups.. nitroglycerin : A nitroglycerol that is glycerol in which the hydrogen atoms of all three hydroxy groups are replaced by nitro groups. It acts as a prodrug, releasing nitric oxide to open blood vessels and so alleviate heart pain.		2.0110nitroglycerolexplosive;
muscle relaxant;
nitric oxide donor;
prodrug;
tocolytic agent;
vasodilator agent;
xenobiotic
omeprazole
Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5.		2.0110aromatic ether;
benzimidazoles;
pyridines;
sulfoxide
oxybutynin
oxybutynin: RN given refers to parent cpd. oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.		2.5820acetylenic compound;
carboxylic ester;
racemate;
tertiary alcohol;
tertiary amino compound		antispasmodic drug;
calcium channel blocker;
local anaesthetic;
muscarinic antagonist;
muscle relaxant;
parasympatholytic
phenoxybenzamine
Phenoxybenzamine: An alpha-adrenergic antagonist with long duration of action. It has been used to treat hypertension and as a peripheral vasodilator.		1.9610aromatic amine
pinacidil
Pinacidil: A guanidine that opens POTASSIUM CHANNELS producing direct peripheral vasodilatation of the ARTERIOLES. It reduces BLOOD PRESSURE and peripheral resistance and produces fluid retention. (Martindale The Extra Pharmacopoeia, 31st ed)		2.0310pyridines
prilocaine
Prilocaine: A local anesthetic that is similar pharmacologically to LIDOCAINE. Currently, it is used most often for infiltration anesthesia in dentistry.. prilocaine : An amino acid amide in which N-propyl-DL-alanine and 2-methylaniline have combined to form the amide bond; used as a local anaesthetic.		6.4533amino acid amide;
monocarboxylic acid amide		anticonvulsant;
local anaesthetic
probucol
Probucol: A drug used to lower LDL and HDL cholesterol yet has little effect on serum-triglyceride or VLDL cholesterol. (From Martindale, The Extra Pharmacopoeia, 30th ed, p993).. probucol : A dithioketal that is propane-2,2-dithiol in which the hydrogens attached to both sulfur atoms are replaced by 3,5-di-tert-butyl-4-hydroxyphenyl groups. An anticholesteremic drug with antioxidant and anti-inflammatory properties, it is used to treat high levels of cholesterol in blood.		2.0410dithioketal;
polyphenol		anti-inflammatory drug;
anticholesteremic drug;
antilipemic drug;
antioxidant;
cardiovascular drug
procaine
Procaine: A local anesthetic of the ester type that has a slow onset and a short duration of action. It is mainly used for infiltration anesthesia, peripheral nerve block, and spinal block. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1016).. procaine : A benzoate ester, formally the result of esterification of 4-aminobenzoic acid with 2-diethylaminoethanol but formed experimentally by reaction of ethyl 4-aminobenzoate with 2-diethylaminoethanol.		4.3522benzoate ester;
substituted aniline;
tertiary amino compound		central nervous system depressant;
drug allergen;
local anaesthetic;
peripheral nervous system drug
propranolol
Propranolol: A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.. propranolol : A propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3.		2.420naphthalenes;
propanolamine;
secondary amine		anti-arrhythmia drug;
antihypertensive agent;
anxiolytic drug;
beta-adrenergic antagonist;
environmental contaminant;
human blood serum metabolite;
vasodilator agent;
xenobiotic
risperidone
Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.		2.1101,2-benzoxazoles;
heteroarylpiperidine;
organofluorine compound;
pyridopyrimidine		alpha-adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
H1-receptor antagonist;
psychotropic drug;
second generation antipsychotic;
serotonergic antagonist
risedronic acid
Risedronic Acid: A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.		2.0410pyridines
sulfamethazine
Sulfamethazine: A sulfanilamide anti-infective agent. It has a spectrum of antimicrobial action similar to other sulfonamides.. sulfamethazine : A sulfonamide consisting of pyrimidine with methyl substituents at the 4- and 6-positions and a 4-aminobenzenesulfonamido group at the 2-position.		1.9710pyrimidines;
sulfonamide antibiotic;
sulfonamide		antibacterial drug;
antiinfective agent;
antimicrobial agent;
carcinogenic agent;
drug allergen;
EC 2.5.1.15 (dihydropteroate synthase) inhibitor;
environmental contaminant;
ligand;
xenobiotic
sulfasalazine
Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907). sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position.		2.1110
terfenadine
Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME.		2.0110diarylmethane
ici 204,219
zafirlukast: a leukotriene D4 receptor antagonist		2.0110carbamate ester;
indoles;
N-sulfonylcarboxamide		anti-asthmatic agent;
leukotriene antagonist
hydrocortisone acetate
hydrocortisone acetate: RN given refers to cpd without isomeric designation		3.0550cortisol ester;
tertiary alpha-hydroxy ketone
mitomycin
Mitomycin: An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.. mitomycin : A family of aziridine-containing natural products isolated from Streptomyces caespitosus or Streptomyces lavendulae.		2.0210mitomycinalkylating agent;
antineoplastic agent
prednisolone
Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.		6.321211beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
drug metabolite;
environmental contaminant;
immunosuppressive agent;
xenobiotic
thymidine
[no description available]		2.0510pyrimidine 2'-deoxyribonucleosideEscherichia coli metabolite;
human metabolite;
metabolite;
mouse metabolite
benzimidazole
1H-benzimidazole : The 1H-tautomer of benzimidazole.		2.0610benzimidazole;
polycyclic heteroarene
hydroxyproline
Hydroxyproline: A hydroxylated form of the imino acid proline. A deficiency in ASCORBIC ACID can result in impaired hydroxyproline formation.. hydroxyproline : A proline derivative that is proline substituted by at least one hydroxy group.		2.9404-hydroxyproline;
L-alpha-amino acid zwitterion		human metabolite;
mouse metabolite;
plant metabolite
thyroxine
Thyroxine: The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.. thyroxine : An iodothyronine compound having iodo substituents at the 3-, 3'-, 5- and 5'-positions.		4.31112-halophenol;
iodophenol;
L-phenylalanine derivative;
non-proteinogenic L-alpha-amino acid;
thyroxine zwitterion;
thyroxine		antithyroid drug;
human metabolite;
mouse metabolite;
thyroid hormone
prednisolone acetate
prednisolone acetate: RN given refers to cpd with locant for acetate group in position 21 & (11 beta)-isomer		4.4451corticosteroid hormone
prednisone
Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.		4.475111-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
immunosuppressive agent;
prodrug
paramethasone
Paramethasone: A glucocorticoid with the general properties of corticosteroids. It has been used by mouth in the treatment of all conditions in which corticosteroid therapy is indicated except adrenal-deficiency states for which its lack of sodium-retaining properties makes it less suitable than HYDROCORTISONE with supplementary FLUDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p737)		2.6330fluorinated steroid
fluprednisolone
Fluprednisolone: A synthetic glucocorticoid with anti-inflammatory properties.		3.0850fluorinated steroid
triiodothyronine
Triiodothyronine: A T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3.. 3,3',5-triiodo-L-thyronine : An iodothyronine compound having iodo substituents at the 3-, 3'- and 5-positions. Although some is produced in the thyroid, most of the 3,3',5-triiodo-L-thyronine in the body is generated by mono-deiodination of L-thyroxine in the peripheral tissues. Its metabolic activity is about 3 to 5 times that of L-thyroxine. The sodium salt is used in the treatment of hypothyroidism.		4.7212-halophenol;
amino acid zwitterion;
iodophenol;
iodothyronine		human metabolite;
mouse metabolite;
thyroid hormone
ethinyl estradiol
Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration.		1.961017-hydroxy steroid;
3-hydroxy steroid;
terminal acetylenic compound		xenoestrogen
1,2-dipalmitoylphosphatidylcholine
1,2-Dipalmitoylphosphatidylcholine: Synthetic phospholipid used in liposomes and lipid bilayers to study biological membranes. It is also a major constituent of PULMONARY SURFACTANTS.		1.9910
desoxycorticosterone
Desoxycorticosterone: A steroid metabolite that is the 11-deoxy derivative of CORTICOSTERONE and the 21-hydroxy derivative of PROGESTERONE		1.961020-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
mineralocorticoid;
primary alpha-hydroxy ketone		human metabolite;
mouse metabolite
colchicine
(S)-colchicine : A colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions.		3.4511alkaloid;
colchicine		anti-inflammatory agent;
gout suppressant;
mutagen
cycloheximide
Cycloheximide: Antibiotic substance isolated from streptomycin-producing strains of Streptomyces griseus. It acts by inhibiting elongation during protein synthesis.. cycloheximide : A dicarboximide that is 4-(2-hydroxyethyl)piperidine-2,6-dione in which one of the hydrogens attached to the carbon bearing the hydroxy group is replaced by a 3,5-dimethyl-2-oxocyclohexyl group. It is an antibiotic produced by the bacterium Streptomyces griseus.		1.9610antibiotic fungicide;
cyclic ketone;
dicarboximide;
piperidine antibiotic;
piperidones;
secondary alcohol		anticoronaviral agent;
bacterial metabolite;
ferroptosis inhibitor;
neuroprotective agent;
protein synthesis inhibitor
fluocinolone acetonide
Fluocinolone Acetonide: A glucocorticoid derivative used topically in the treatment of various skin disorders. It is usually employed as a cream, gel, lotion, or ointment. It has also been used topically in the treatment of inflammatory eye, ear, and nose disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732). fluocinolone acetonide : A fluorinated steroid that is flunisolide in which the hydrogen at position 9 is replaced by fluorine. A corticosteroid with glucocorticoid activity, it is used (both as the anhydrous form and as the dihydrate) in creams, gels and ointments for the treatment of various skin disorders.		6.941011beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
organic heteropentacyclic compound;
primary alpha-hydroxy ketone		anti-inflammatory drug;
antipruritic drug
triamcinolone diacetate
triamcinolone diacetate: lysyl oxidase antagonist; Polcortolon may also refers to triamcinolone		3.4620corticosteroid hormone
arginine
Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group.		2.1710arginine;
glutamine family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		biomarker;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical
triamcinolone acetonide
Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections.		11.8939911beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
cyclic ketal;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
acrylic acid
acrylic acid: RN given refers to parent cpd. acrylic acid : A alpha,beta-unsaturated monocarboxylic acid that is ethene substituted by a carboxy group.		2.1710alpha,beta-unsaturated monocarboxylic acidmetabolite
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		22.536761546-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
1,2-dihydroxybenzene-3,5-disulfonic acid disodium salt
Chymopapain: A cysteine endopeptidase isolated from papaya latex. Preferential cleavage at glutamic and aspartic acid residues. EC 3.4.22.6.		2.3720organosulfur compound;
sulfonic acid derivative
adamantane
Adamantane: A tricyclo bridged hydrocarbon.		2.1510adamantanes;
polycyclic alkane
isoxazoles
Isoxazoles: Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions.. isoxazole : A monocyclic heteroarene with a structure consisting of a 5-membered ring containing three carbon atoms and an oxygen and nitrogen atom adjacent to each other. It is the parent of the class of isoxazoles.. isoxazoles : Oxazoles in which the N and O atoms are adjacent.		1.9710isoxazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
dexamethasone 21-phosphate
dexamethasone 21-phosphate: has anti-inflammatory activity. dexamethasone phosphate : A steroid phosphate that is the 21-O-phospho derivative of dexamethasone.		4.888011beta-hydroxy steroid;
17-hydroxy steroid;
3-oxo-Delta(4) steroid;
fluorinated steroid;
steroid phosphate;
tertiary alpha-hydroxy ketone		glucocorticoid receptor agonist
betamethasone
Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)		10.5717611beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-asthmatic agent;
anti-inflammatory drug;
immunosuppressive agent
malondialdehyde
Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form.		3.0140dialdehydebiomarker
trimecaine
Trimecaine: Acetanilide derivative used as a local anesthetic.		2.5220amino acid amide
durapatite
Durapatite: The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.. hydroxylapatite : A phosphate mineral with the formula Ca5(PO4)3(OH).		2.1310
flumethasone
Flumethasone: An anti-inflammatory glucocorticoid used in veterinary practice.		1.961011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
methylprednisolone hemisuccinate
Methylprednisolone Hemisuccinate: A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.		6.55102corticosteroid hormone;
hemisuccinate
1-myristylpicolinium
1-myristylpicolinium: suppresses cartilage & synovial membrane glycosaminoglycan sythesis; RN refers to chloride		2.940
(3-mercaptopropyl)trimethoxysilane
[no description available]		2.1710
fructosamine
Fructosamine: An amino sugar formed when glucose non-enzymatically reacts with the N-terminal amino group of proteins. The fructose moiety is derived from glucose by the classical Amadori rearrangement.		7.1310
triamcinolone hexacetonide
triamcinolone hexacetonide: structure		7.2562corticosteroid hormone
gold
Gold: A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.		3.3611copper group element atom;
elemental gold
tricalcium phosphate
tricalcium phosphate: a form of tricalcium phosphate used as bioceramic bone replacement material; see also records for alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium phosphate; apatitic tricalcium phosphate Ca9(HPO4)(PO4)5(OH) is the calcium orthophosphate leading to beta tricalcium phosphate Ca3(PO4)2 (b-TCP). calcium phosphate : A calcium salt composed of calcium and phosphate/diphosphate ions; present in milk and used for the mineralisation of calcified tissues.		3.8821calcium phosphate
ozone
Ozone: The unstable triatomic form of oxygen, O3. It is a powerful oxidant that is produced for various chemical and industrial uses. Its production is also catalyzed in the ATMOSPHERE by ULTRAVIOLET RAY irradiation of oxygen or other ozone precursors such as VOLATILE ORGANIC COMPOUNDS and NITROGEN OXIDES. About 90% of the ozone in the atmosphere exists in the stratosphere (STRATOSPHERIC OZONE).. ozone : An elemental molecule with formula O3. An explosive, pale blue gas (b.p. -112degreeC) that has a characteristic, pungent odour, it is continuously produced in the upper atmosphere by the action of solar ultraviolet radiation on atmospheric oxygen. It is an antimicrobial agent used in the production of bottled water, as well as in the treatment of meat, poultry and other foodstuffs.		6.342elemental molecule;
gas molecular entity;
reactive oxygen species;
triatomic oxygen		antiseptic drug;
disinfectant;
electrophilic reagent;
greenhouse gas;
mutagen;
oxidising agent;
tracer
trolamine salicylate
Arthritis: Acute or chronic inflammation of JOINTS.		6.13123
cephalexin
Cephalexin: A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.. cephalexin : A semisynthetic first-generation cephalosporin antibiotic having methyl and beta-(2R)-2-amino-2-phenylacetamido groups at the 3- and 7- of the cephem skeleton, respectively. It is effective against both Gram-negative and Gram-positive organisms, and is used for treatment of infections of the skin, respiratory tract and urinary tract.		1.9610beta-lactam antibiotic allergen;
cephalosporin;
semisynthetic derivative		antibacterial drug
phenyl acetate
phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid.		2.3420benzenes;
phenyl acetates
triamcinolone
Triamcinolone: A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739). triamcinolone : A C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections.		7.312111beta-hydroxy steroid;
16alpha-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid hormone;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
glutamic acid
Glutamic Acid: A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.. glutamic acid : An alpha-amino acid that is glutaric acid bearing a single amino substituent at position 2.		2.110glutamic acid;
glutamine family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		Escherichia coli metabolite;
ferroptosis inducer;
micronutrient;
mouse metabolite;
neurotransmitter;
nutraceutical
timolol
(S)-timolol (anhydrous) : The (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine.		2.1710timololanti-arrhythmia drug;
antiglaucoma drug;
antihypertensive agent;
beta-adrenergic antagonist
paclitaxel
Taxus: Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).		2.110taxane diterpenoid;
tetracyclic diterpenoid		antineoplastic agent;
human metabolite;
metabolite;
microtubule-stabilising agent
propiconazole
Orbit: Bony cavity that holds the eyeball and its associated tissues and appendages.		4.6461conazole fungicide;
cyclic ketal;
dichlorobenzene;
triazole fungicide;
triazoles		antifungal agrochemical;
EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor;
environmental contaminant;
xenobiotic
fomesafen
fomesafen: a protoporphyrinogen oxidase-inhibiting herbicide. fomesafen : An N-sulfonylcarboxamide that is N-(methylsulfonyl)benzamide in which the phenyl ring is substituted by a nitro group at position 2 and a 2-chloro-4-(trifluoromethyl)phenoxy group at position 5. A protoporphyrinogen oxidase inhibitor, it was specially developed for use (generally as the corresponding sodium salt, fomesafen-sodium) for post-emergence control of broad-leaf weeds in soya.		2.0210aromatic ether;
C-nitro compound;
monochlorobenzenes;
N-sulfonylcarboxamide;
organofluorine compound;
phenols		agrochemical;
EC 1.3.3.4 (protoporphyrinogen oxidase) inhibitor;
herbicide
lovastatin
Lovastatin: A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.. lovastatin : A fatty acid ester that is mevastatin carrying an additional methyl group on the carbobicyclic skeleton. It is used in as an anticholesteremic drug and has been found in fungal species such as Aspergillus terreus and Pleurotus ostreatus (oyster mushroom).		2.0410delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
polyketide;
statin (naturally occurring)		anticholesteremic drug;
antineoplastic agent;
Aspergillus metabolite;
prodrug
pravastatin
Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin.		2.07103-hydroxy carboxylic acid;
carbobicyclic compound;
carboxylic ester;
hydroxy monocarboxylic acid;
secondary alcohol;
statin (semi-synthetic)		anticholesteremic drug;
environmental contaminant;
metabolite;
xenobiotic
mifepristone
Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.		2.91103-oxo-Delta(4) steroid;
acetylenic compound;
tertiary amino compound		abortifacient;
contraceptive drug;
hormone antagonist;
synthetic oral contraceptive
betamethasone sodium phosphate
betamethasone sodium phosphate: phosphate ester of betamethasone; RN given refers to the di-Na salt (11beta,16beta)-isomer; structure in Negwer,5th ed, 4975. betamethasone sodium phosphate : An organic sodium salt that is the disodium salt of betamethasone phosphate.		3.8140organic sodium salt;
tertiary alpha-hydroxy ketone
iopamidol
Iopamidol: A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.. iopamidol : A benzenedicarboxamide compound having N-substituted carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and a (2S)-2-hydroxypropanamido group at the 5-position.		2.0610benzenedicarboxamide;
organoiodine compound;
pentol		environmental contaminant;
radioopaque medium;
xenobiotic
triazoles
Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms.		2.98401,2,3-triazole
voriconazole
Voriconazole: A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.. voriconazole : A triazole-based antifungal agent used for the treatment of esophageal candidiasis, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. It is an inhibitor of cytochrome P450 2C9 (CYP2C9) and CYP3A4.		2.9840conazole antifungal drug;
difluorobenzene;
pyrimidines;
tertiary alcohol;
triazole antifungal drug		P450 inhibitor
prednisolone phosphate
prednisolone phosphate: RN given refers to (11 beta)-isomer. prednisolone phosphate : A synthetic glucocorticoid resulting from the formal condensation of the 21-hydroxy group of prednisolone with one of the hydroxy groups of phosphoric acid. It is a prodrug for prednisolone that is activated in vivo by phosphatases.		1.931011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
glucocorticoid;
steroid phosphate;
tertiary alpha-hydroxy ketone		anti-inflammatory agent;
antineoplastic agent;
glucocorticoid receptor agonist;
prodrug
octadecyl palmitate
octadecyl palmitate: found in psoriatic nail, but not in normal nails. stearyl palmitate : A palmitate ester resulting from the formal condensation of the carboxy group of palmitic acid with the hydroxy group of stearyl alcohol.		2.0810hexadecanoate ester;
wax ester		coral metabolite;
cosmetic
fibrinogen
Fibrinogen: Plasma glycoprotein clotted by thrombin, composed of a dimer of three non-identical pairs of polypeptide chains (alpha, beta, gamma) held together by disulfide bonds. Fibrinogen clotting is a sol-gel change involving complex molecular arrangements: whereas fibrinogen is cleaved by thrombin to form polypeptides A and B, the proteolytic action of other enzymes yields different fibrinogen degradation products.. D-iditol : The D-enantiomer of iditol.		1.9710iditolfungal metabolite
halopredone acetate
halopredone acetate: RN given refers to (6beta,11beta)-isomer; structure		2.6630organic molecular entity
levobupivacaine
Levobupivacaine: S-enantiomer of bupivacaine that is used as a local anesthetic and for regional nerve blocks, including EPIDURAL ANESTHESIA.. levobupivacaine : The (S)-(-)-enantiomer of bupivacaine.		3.45111-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamideadrenergic antagonist;
amphiphile;
EC 3.1.1.8 (cholinesterase) inhibitor;
EC 3.6.3.8 (Ca(2+)-transporting ATPase) inhibitor;
local anaesthetic
foxes
Foxes: Any of several carnivores in the family CANIDAE, that possess erect ears and long bushy tails and are smaller than WOLVES. They are classified in several genera and found on all continents except Antarctica.		2.3920
eudragit rs
Eudragit RS: copolymer of acrylic & methacrylic acid esters & quaternary ammonium groups; used for microcapsules		2.4820
u 78517f
U 78517F: iron-catalyzed lipid peroxidation inhibitor; structure given in first source; RN given is for diHCl		1.9810
1-hexadecyl-2-acetyl-glycero-3-phosphocholine
Platelet Activating Factor: A phospholipid derivative formed by PLATELETS; BASOPHILS; NEUTROPHILS; MONOCYTES; and MACROPHAGES. It is a potent platelet aggregating agent and inducer of systemic anaphylactic symptoms, including HYPOTENSION; THROMBOCYTOPENIA; NEUTROPENIA; and BRONCHOCONSTRICTION.. 2-O-acetyl-1-O-hexadecyl-sn-glycero-3-phosphocholine : A 2-acetyl-1-alkyl-sn-glycero-3-phosphocholine betaine which has hexadecyl as the alkyl group. PAF is a potent phospholipid activator and mediator of many leukocyte functions, including platelet aggregation, inflammation, and anaphylaxis.		1.99102-acetyl-1-alkyl-sn-glycero-3-phosphocholineantihypertensive agent;
beta-adrenergic antagonist;
bronchoconstrictor agent;
hematologic agent;
vasodilator agent
tadalafil
[no description available]		2.0510benzodioxoles;
pyrazinopyridoindole		EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor;
vasodilator agent
betamethasone acetate phosphate
betamethasone acetate phosphate: RN given refers to parent mixt.		3.3411
technetium tc 99m hydroxymethylene diphosphonate
technetium Tc 99m hydroxymethylene diphosphonate: bone-seeking radiopharmaceutical		2.1110
7,8-dichloro-1,2,3,4-tetrahydroisoquinoline
7,8-dichloro-1,2,3,4-tetrahydroisoquinoline: potent reversible inhibitor of phenylethanolamine N-methyltransferase; structure. 7,8-dichloro-1,2,3,4-tetrahydroisoquinoline : A 1,2,3,4-tetrahydroisoquinoline hacing chloro substituents at the 7- and 8-positions.		1.9610isoquinolines;
organochlorine compound
methotrexate
[no description available]		4.3241dicarboxylic acid;
monocarboxylic acid amide;
pteridines		abortifacient;
antimetabolite;
antineoplastic agent;
antirheumatic drug;
dermatologic drug;
DNA synthesis inhibitor;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor;
immunosuppressive agent
carbapenems
[no description available]		2.110
betamethasone-17,21-dipropionate
betamethasone-17,21-dipropionate: may also contain chlorocresol (UD 25:22R)		1.9810
naproxen
Naproxen: An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.. naproxen : A methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes.		3.3611methoxynaphthalene;
monocarboxylic acid		antipyretic;
cyclooxygenase 1 inhibitor;
cyclooxygenase 2 inhibitor;
drug allergen;
environmental contaminant;
gout suppressant;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug;
xenobiotic
ropivacaine
Ropivacaine: An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.. ropivacaine : The piperidinecarboxamide obtained by the formal condensation of N-propylpipecolic acid and 2,6-dimethylaniline.. (S)-ropivacaine : A piperidinecarboxamide-based amide-type local anaesthetic (amide caine) in which (S)-N-propylpipecolic acid and 2,6-dimethylaniline are combined to form the amide bond.		7.4320piperidinecarboxamide;
ropivacaine		local anaesthetic
cortisone
[no description available]		7.031011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		human metabolite;
mouse metabolite
isoflupredone acetate
isoflupredone acetate: RN refers to (11beta)-isomer; structure		2.4420corticosteroid hormone
epinastine
dexamethasone acetate: RN given refers to (11beta,16alpha)-isomer		1.9610corticosteroid hormone
cimadronate
cimadronate: increases serum 1,25-dihydroxyvitamin D in rats via stimulating renal 1-hydroxylase activity; structure given in first source		2.0210
dihydropyridines
Dihydropyridines: Pyridine moieties which are partially saturated by the addition of two hydrogen atoms in any position.		2.2510
fibrin
Fibrin: A protein derived from FIBRINOGEN in the presence of THROMBIN, which forms part of the blood clot.		1.9910peptide
glucosamine
D-glucosamine : An amino sugar whose structure comprises D-glucose having an amino substituent at position 2.. 2-amino-2-deoxy-D-glucopyranose : A D-glucosamine whose structure comprises D-glucopyranose having an amino substituent at position 2.		7.0410D-glucosamineEscherichia coli metabolite;
geroprotector;
mouse metabolite
epiglucan
epiglucan: a highly side-chain/branched alkali-insoluble cell wall glucan from fungus such as Epicoccum nigrum, Botrytis cinerea, ascomycetes & basidiomycetes; also isolated S-4001 from Lei Wan (polyporus mylitiae), HA-beta-glucan from mushroom Pleutotus ostreatus (Fr.) Quel., and translam from seaweed Laminaria cichorioides; with commercially important functional properties including emulsification and friction reduction.		2.0810
betadex
beta-Cyclodextrins: Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds.		2.1710cyclodextrin
tretinoin
Tretinoin: An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).. retinoic acid : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraenoic acid substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified).. all-trans-retinoic acid : A retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry.		210retinoic acid;
vitamin A		anti-inflammatory agent;
antineoplastic agent;
antioxidant;
AP-1 antagonist;
human metabolite;
keratolytic drug;
retinoic acid receptor agonist;
retinoid X receptor agonist;
signalling molecule
tacrolimus
Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.		2.2510macrolide lactambacterial metabolite;
immunosuppressive agent
mycophenolic acid
Mycophenolic Acid: Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.. mycophenolate : A monocarboxylic acid anion resulting from the removal of a proton from the carboxy group of mycophenolic acid.. mycophenolic acid : A member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases.		1.99102-benzofurans;
gamma-lactone;
monocarboxylic acid;
phenols		anticoronaviral agent;
antimicrobial agent;
antineoplastic agent;
EC 1.1.1.205 (IMP dehydrogenase) inhibitor;
environmental contaminant;
immunosuppressive agent;
mycotoxin;
Penicillium metabolite;
xenobiotic
keratan sulfate
Keratan Sulfate: A sulfated mucopolysaccharide initially isolated from bovine cornea. At least two types are known. Type I, found mostly in the cornea, contains D-galactose and D-glucosamine-6-O-sulfate as the repeating unit; type II, found in skeletal tissues, contains D-galactose and D-galactosamine-6-O-sulfate as the repeating unit.. keratan sulfate : A sulfated glycosaminoglycan, a linear polymer that consists of the repeating disaccharide [3)-beta-Gal-(1->4)-beta-GlcNAc-(1->] and containing sulfo groups located at random positions.. keratan 6'-sulfate : A keratan sulfate with random sulfation at the 6'-position.		3.7821
alitretinoin
Alitretinoin: A retinoid that is used for the treatment of chronic hand ECZEMA unresponsive to topical CORTICOSTEROIDS. It is also used to treat cutaneous lesions associated with AIDS-related KAPOSI SARCOMA.		210retinoic acidantineoplastic agent;
keratolytic drug;
metabolite;
retinoid X receptor agonist
sodium bicarbonate
Sodium Bicarbonate: A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.		3.4211one-carbon compound;
organic sodium salt		antacid;
food anticaking agent
arginine vasopressin
Arginine Vasopressin: The predominant form of mammalian antidiuretic hormone. It is a nonapeptide containing an ARGININE at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. Arg-vasopressin is used to treat DIABETES INSIPIDUS or to improve vasomotor tone and BLOOD PRESSURE.. argipressin : The predominant form of mammalian vasopressin (antidiuretic hormone). It is a nonapeptide containing an arginine at residue 8 and two disulfide-linked cysteines at residues of 1 and 6.		1.9610vasopressincardiovascular drug;
hematologic agent;
mitogen
prednisolone hemisuccinate
prednisolone hemisuccinate: RN given refers to (11 beta)-isomer. prednisolone succinate : A hemisuccinate resulting from the formal condensation of the 21-hydroxy group prednisolone with one of the carboxy groups of succinic acid. It is used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns.		2.021011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
hemisuccinate;
tertiary alpha-hydroxy ketone		anti-inflammatory drug
propylthiouracil
Propylthiouracil: A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534). 6-propyl-2-thiouracil : A pyrimidinethione consisting of uracil in which the 2-oxo group is substituted by a thio group and the hydrogen at position 6 is substituted by a propyl group.		1.9910pyrimidinethioneantidote to paracetamol poisoning;
antimetabolite;
antioxidant;
antithyroid drug;
carcinogenic agent;
EC 1.14.13.39 (nitric oxide synthase) inhibitor;
hormone antagonist
ranitidine
Ranitidine: A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.. ranitidine : A member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease.		2.0110C-nitro compound;
furans;
organic sulfide;
tertiary amino compound		anti-ulcer drug;
drug allergen;
environmental contaminant;
H2-receptor antagonist;
xenobiotic
mtt formazan
MTT formazan: a blue MEM-insoluble mitochondrial byproduct; used to determine viability of cells with active mitochondrial dehydrogenase enzymes		2.0610
osteoprotegerin
Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B.		2.5820long-chain fatty acid
bilirubin
[no description available]		2.1110biladienes;
dicarboxylic acid		antioxidant;
human metabolite;
mouse metabolite
dinoprostone
prostaglandin E2 : Prostaglandin F2alpha in which the hydroxy group at position 9 has been oxidised to the corresponding ketone. Prostaglandin E2 is the most common and most biologically potent of mammalian prostaglandins.		4.7721prostaglandins Ehuman metabolite;
mouse metabolite;
oxytocic
amphotericin b
Amphotericin B: Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.. amphotericin B : A macrolide antibiotic used to treat potentially life-threatening fungal infections.		1.9610antibiotic antifungal drug;
macrolide antibiotic;
polyene antibiotic		antiamoebic agent;
antiprotozoal drug;
bacterial metabolite
pulmicort
Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis.		3.351111beta-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
cyclic acetal;
glucocorticoid;
primary alpha-hydroxy ketone		anti-inflammatory drug;
bronchodilator agent;
drug allergen
paricalcitol
[no description available]		2.0510hydroxy seco-steroid;
seco-cholestane		antiparathyroid drug
coenzyme q10
coenzyme Q10: Ubiquinone ring with a chain of 10 isoprene units; redox equilibrium with ubiqunol serving in mitochondrial inner membrane to transfer electrons; presence during reconstitution of acetylcholine receptor into phospholipid vesicles yields vesicles active in catalyzing carbamylcholine-sensitive Na+ flux; coenzyme Q10 depletion has been noted with use of statins. coenzyme Q10 : A ubiquinone having a side chain of 10 isoprenoid units. In the naturally occurring isomer, all isoprenyl double bonds are in the E- configuration.		2.110ubiquinonesantioxidant;
ferroptosis inhibitor;
human metabolite
pitavastatin
pitavastatin : A dihydroxy monocarboxylic acid that is (6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]hept-6-enoic acid in which the two hydroxy groups are located at positions 3 and 5 (the 3R,5S-stereoisomer). Used as its calcium salt for treatment of hypercholesterolemia (elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise.		2.0410cyclopropanes;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
quinolines;
statin (synthetic)		antioxidant
codeine
[no description available]		8.3511morphinane alkaloid;
organic heteropentacyclic compound		antitussive;
drug allergen;
environmental contaminant;
opioid analgesic;
opioid receptor agonist;
prodrug;
xenobiotic
morphine
Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn.		3.821morphinane alkaloid;
organic heteropentacyclic compound;
tertiary amino compound		anaesthetic;
drug allergen;
environmental contaminant;
geroprotector;
mu-opioid receptor agonist;
opioid analgesic;
plant metabolite;
vasodilator agent;
xenobiotic
clobetasol
Clobetasol: A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.. clobetasol : A 3-oxo-Delta(1),Delta(4)-steroid that is 16beta-methylpregna-1,4-diene-3,20-dione bearing hydroxy groups at the 11beta and 17alpha positions, fluorine at position 9, and a chlorine substituent at position 21. It is used as its 17alpha-propionate ester to treat various skin disorders, including exzema and psoriasis.		2.151011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
3-oxo-Delta(1),Delta(4)-steroid;
chlorinated steroid;
fluorinated steroid;
glucocorticoid;
tertiary alpha-hydroxy ketone		anti-inflammatory drug;
SMO receptor agonist
goserelin
Goserelin: A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.		1.9810organic molecular entity
lacidipine
[no description available]		2.2510cinnamate ester;
tert-butyl ester
pregabalin
Pregabalin: A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.. pregabalin : A gamma-amino acid that is gamma-aminobutyric acid (GABA) carrying an isobutyl substitutent at the beta-position (the S-enantiomer). Binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues.		3.1710gamma-amino acidanticonvulsant;
calcium channel blocker
saralasin
Saralasin: An octapeptide analog of angiotensin II (bovine) with amino acids 1 and 8 replaced with sarcosine and alanine, respectively. It is a highly specific competitive inhibitor of angiotensin II that is used in the diagnosis of HYPERTENSION.		1.9610oligopeptide
gadolinium dtpa
Gadolinium DTPA: A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see PENTETIC ACID), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)		5.0431gadolinium coordination entityMRI contrast agent
formazans
Formazans: Colored azo compounds formed by the reduction of tetrazolium salts. Employing this reaction, oxidoreductase activity can be determined quantitatively in tissue sections by allowing the enzymes to act on their specific substrates in the presence of tetrazolium salts.		2.0610
adarotene
adarotene: structure in first source		2.1510
thiocolchicoside
thiocolchicoside: used in combination with glafenine and meprobamate to tranquilize patients undergoing hysterosalpingography; structure		3.8521glycoside
losartan potassium
Erythropoietin: Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation.		2.3920
dextrothyroxine
[no description available]		2.0610
acid phosphatase
Acid Phosphatase: An enzyme that catalyzes the conversion of an orthophosphoric monoester and water to an alcohol and orthophosphate. EC 3.1.3.2.		1.9610
methylprednisolone 17-hemisuccinate
methylprednisolone 17-hemisuccinate: Mesh term is for the 21-succinate; RN given refers to (6alpha,11beta)-isomer		1.9610
jaw
[no description available]		3.3911indolecarboxamide
calcitonin
[no description available]		2.6930
cosyntropin
Cosyntropin: A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of ADRENOCORTICOTROPIC HORMONE. ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates production of CORTICOSTEROIDS in the ADRENAL CORTEX.. cosyntropin : A synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone (corticotropin). A segment similar in all species, it contains the biological activity that stimulates production of corticosteroids in the adrenal cortex. It is used diagnostically to investigate adrenocortical insufficiency.		1.9610
cellulose
DEAE-Cellulose: Cellulose derivative used in chromatography, as ion-exchange material, and for various industrial applications.		2.1710glycoside
phosphatidylcholines
Phosphatidylcholines: Derivatives of PHOSPHATIDIC ACIDS in which the phosphoric acid is bound in ester linkage to a CHOLINE moiety.		2.25101,2-diacyl-sn-glycero-3-phosphocholine
ubiquinone
Ubiquinone: A lipid-soluble benzoquinone which is involved in ELECTRON TRANSPORT in mitochondrial preparations. The compound occurs in the majority of aerobic organisms, from bacteria to higher plants and animals.		2.110
chitosan
[no description available]		2.1310
delta7-dafachronic acid
delta7-dafachronic acid: structure in first source. (25S)-Delta(7)-dafachronic acid : A Delta(7)-dafachronic acid that has S configuration at position 25 (the carbon attached to the carboxy group).		2.1710Delta(7)-dafachronic acidCaenorhabditis elegans metabolite
cortisol succinate, sodium salt
hydrocortisone hemisuccinate: RN given refers to (11beta)-isomer; Synonyms Solu-Cortef & sopolcort H refer to Na salt		1.9610organic molecular entity
ethyl cellulose
[no description available]		2.1710glycoside
interleukin-8
Interleukin-8: A member of the CXC chemokine family that plays a role in the regulation of the acute inflammatory response. It is secreted by variety of cell types and induces CHEMOTAXIS of NEUTROPHILS and other inflammatory cells.		5.8221
colistin
Colistin: Cyclic polypeptide antibiotic from Bacillus colistinus. It is composed of Polymyxins E1 and E2 (or Colistins A, B, and C) which act as detergents on cell membranes. Colistin is less toxic than Polymyxin B, but otherwise similar; the methanesulfonate is used orally.. colistin : A multi-component mixture comprising mostly of colistin A (R = Me) and B (R = H), with small amounts of colistin C and other polymyxins, produced by certain strains of Bacillus polymyxa var. colistinus. An antibiotic, it is used as its sulfate salt (for oral or topical use) or as the sodium salt of the N-methylsulfonic acid derivative (the injectable form) in the treatment of severe Gram-negative infections, partiularly those due to Pseudomonas aeruginosa.		2.110
tylosin
[no description available]		2.0410
ascorbic acid
Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.. L-ascorbic acid : The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.. L-ascorbate : The L-enantiomer of ascorbate and conjugate base of L-ascorbic acid, arising from selective deprotonation of the 3-hydroxy group. Required for a range of essential metabolic reactions in all animals and plants.. vitamin C : Any member of a group of vitamers that belong to the chemical structural class called butenolides that exhibit biological activity against vitamin C deficiency in animals. The vitamers include L-ascorbic acid and its salt, ionized and oxidized forms.		2.4220ascorbic acid;
vitamin C		coenzyme;
cofactor;
flour treatment agent;
food antioxidant;
food colour retention agent;
geroprotector;
plant metabolite;
skin lightening agent
tetracycline
Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria.		210
minocycline
Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5.		2.110
piroxicam
[no description available]		4.7732benzothiazine;
monocarboxylic acid amide;
pyridines		analgesic;
antirheumatic drug;
cyclooxygenase 1 inhibitor;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-steroidal anti-inflammatory drug
mobic
Meloxicam: A benzothiazine and thiazole derivative that acts as a NSAID and cyclooxygenase-2 (COX-2) inhibitor. It is used in the treatment of RHEUMATOID ARTHRITIS; OSTEOARTHRITIS; and ANKYLOSING SPONDYLITIS.. meloxicam : A benzothiazine that is piroxicam in which the pyridin-2-yl group is replaced by a 5-methyl-1,3-thiazol-2-yl group. A non-steroidal anti-inflammatory drug and selective inhibitor of COX-2, it is used particularly for the management of rheumatoid arthritis.		2.05101,3-thiazoles;
benzothiazine;
monocarboxylic acid amide		analgesic;
antirheumatic drug;
cyclooxygenase 2 inhibitor;
non-steroidal anti-inflammatory drug
mobiflex
tenoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries.		4.7732heteroaryl hydroxy compound;
monocarboxylic acid amide;
pyridines;
thienothiazine		antipyretic;
EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor;
non-narcotic analgesic;
non-steroidal anti-inflammatory drug
warfarin
Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group.		2.0410benzenes;
hydroxycoumarin;
methyl ketone
tigecycline
[no description available]		2.110
epidermal growth factor
Epidermal Growth Factor: A 6-kDa polypeptide growth factor initially discovered in mouse submaxillary glands. Human epidermal growth factor was originally isolated from urine based on its ability to inhibit gastric secretion and called urogastrone. Epidermal growth factor exerts a wide variety of biological effects including the promotion of proliferation and differentiation of mesenchymal and EPITHELIAL CELLS. It is synthesized as a transmembrane protein which can be cleaved to release a soluble active form.		1.9910
transforming growth factor beta
Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins.		4.341
epoetin alfa
Epoetin Alfa: A recombinant glycosylated form of erythropoietin which stimulates the differentiation and proliferation of erythroid precursors. It is used for the treatment of ANEMIA associated with CHRONIC RENAL FAILURE in dialysis and predialysis patients.		2.0310
transforming growth factor alpha
Transforming Growth Factor alpha: An EPIDERMAL GROWTH FACTOR related protein that is found in a variety of tissues including EPITHELIUM, and maternal DECIDUA. It is synthesized as a transmembrane protein which can be cleaved to release a soluble active form which binds to the EGF RECEPTOR.		1.9910
cyclosporine
Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).		3.8221
technetium tc 99m medronate
Technetium Tc 99m Medronate: A gamma-emitting radionuclide imaging agent used primarily in skeletal scintigraphy. Because of its absorption by a variety of tumors, it is useful for the detection of neoplasms.		2.1110
sodium morrhuate
Sodium Morrhuate: The sodium salts of the fatty acids in cod liver oil; an irritant and sclerosing agent used to treat varicose veins and arthritic joints.		5.822
acyclovir
Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections.		4.35112-aminopurines;
oxopurine		antimetabolite;
antiviral drug
olanzapine
Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4.		2.0510benzodiazepine;
N-arylpiperazine;
N-methylpiperazine		antiemetic;
dopaminergic antagonist;
histamine antagonist;
muscarinic antagonist;
second generation antipsychotic;
serotonergic antagonist;
serotonin uptake inhibitor
allopurinol
Allopurinol: A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.. allopurinol : A bicyclic structure comprising a pyrazole ring fused to a hydroxy-substituted pyrimidine ring.		1.9910nucleobase analogue;
organic heterobicyclic compound		antimetabolite;
EC 1.17.3.2 (xanthine oxidase) inhibitor;
gout suppressant;
radical scavenger
avermectin
avermectin: produced by actinomycete, Streptomyces avermitilis; structure; see also records for specific avermectins. avermectin : Any of the macrolides obtained as fermentation products from the bacterium Streptomyces avermitilis and consisting of a 16-membered macrocyclic backbone that is fused both benzofuran and spiroketal functions and contains a disaccharide substituent. They have significant anthelmintic and insecticidal properties.		2.0610
eye
[no description available]		10.0252
leptin
Leptin: A 16-kDa peptide hormone secreted from WHITE ADIPOCYTES. Leptin serves as a feedback signal from fat cells to the CENTRAL NERVOUS SYSTEM in regulation of food intake, energy balance, and fat storage.		2.1510
ConditionIndicatedRelationship StrengthStudiesTrials
Innate Inflammatory Response
[description not available]		06.2121
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		011.2121
Benign Neoplasms
[description not available]		03.0310
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		03.0310
Anemia, Fanconi
[description not available]		02.1310
Fanconi Anemia
Congenital disorder affecting all bone marrow elements, resulting in ANEMIA; LEUKOPENIA; and THROMBOPENIA, and associated with cardiac, renal, and limb malformations as well as dermal pigmentary changes. Spontaneous CHROMOSOME BREAKAGE is a feature of this disease along with predisposition to LEUKEMIA. There are at least 7 complementation groups in Fanconi anemia: FANCA, FANCB, FANCC, FANCD1, FANCD2, FANCE, FANCF, FANCG, and FANCL. (from Online Mendelian Inheritance in Man, http://www.ncbi.nlm.nih.gov/entrez/dispomim.cgi?id=227650, August 20, 2004)		02.1310
Epicondylitis, Lateral Humeral
[description not available]		08.63106
Tennis Elbow
A condition characterized by pain in or near the lateral humeral epicondyle or in the forearm extensor muscle mass as a result of unusual strain. It occurs due repetitive stresses on the elbow from activities such as tennis playing.		110.63106
Cold Panniculitis
[description not available]		02.4110
Cat Diseases
Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used.		05.99142
Aseptic Necrosis of Bone
[description not available]		03.6690
Osteonecrosis
Death of a bone or part of a bone, either atraumatic or posttraumatic.		03.6690
Seroma
Tumor-like sterile accumulation of serum in a tissue, organ, or cavity. It results from a tissue insult and is the product of tissue inflammation. It most commonly occurs following MASTECTOMY.		05.1433
Breast Cancer
[description not available]		05.5832
Complication, Postoperative
[description not available]		08.24155
Breast Neoplasms
Tumors or cancer of the human BREAST.		05.5832
Postoperative Complications
Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.		08.24155
Equine Diseases
[description not available]		03.95130
Ache
[description not available]		013.264517
Pain
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.		115.264517
Disc, Herniated
[description not available]		012.643017
Intervertebral Disc Displacement
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.		012.643017
Arthritis, Degenerative
[description not available]		011.132712
Osteoarthritis
A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans.		113.132712
Cardiac Failure
[description not available]		02.610
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		07.4220
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.		07.610
Absence Seizure
[description not available]		02.4820
Rodent Diseases
Diseases of rodents of the order RODENTIA. This term includes diseases of Sciuridae (squirrels), Geomyidae (gophers), Heteromyidae (pouched mice), Castoridae (beavers), Cricetidae (rats and mice), Muridae (Old World rats and mice), Erethizontidae (porcupines), and Caviidae (guinea pigs).		02.4220
Seizures
Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder.		02.4820
Granulomatous Mastitis
A rare, benign, inflammatory breast disease occurring in premenopausal women shortly after a recent pregnancy. The origin is unknown but it is commonly mistaken for malignancy and sometimes associated with BREAST FEEDING and the use of ORAL CONTRACEPTIVES.		02.2510
Bone Cysts
Benign unilocular lytic areas in the proximal end of a long bone with well defined and narrow endosteal margins. The cysts contain fluid and the cyst walls may contain some giant cells. Bone cysts usually occur in males between the ages 3-15 years.		012.59398
Fracture, Pathologic
[description not available]		03.5990
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		04.69280
Blood Pressure, High
[description not available]		03.360
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.		03.360
Asthma, Bronchial
[description not available]		02.6730
Asthma
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).		19.6730
Dermatosclerosis
[description not available]		02.2510
Scleroderma, Localized
A term used to describe a variety of localized asymmetrical SKIN thickening that is similar to those of SYSTEMIC SCLERODERMA but without the disease features in the multiple internal organs and BLOOD VESSELS. Lesions may be characterized as patches or plaques (morphea), bands (linear), or nodules.		02.2510
Retinal Diseases
Diseases involving the RETINA.		02.9140
De Quervain Disease
Stenosing tenosynovitis of the abductor pollicis longus and extensor pollicis brevis tendons in the first dorsal wrist compartment. The presenting symptoms are usually pain and tenderness at the radial styloid. The cause is almost always related to OVERUSE INJURY or is associated with RHEUMATOID ARTHRITIS.		06.2866
Tenosynovitis
Inflammation of the synovial lining of a tendon sheath. Causes include trauma, tendon stress, bacterial disease (gonorrhea, tuberculosis), rheumatic disease, and gout. Common sites are the hand, wrist, shoulder capsule, hip capsule, hamstring muscles, and Achilles tendon. The tendon sheaths become inflamed and painful, and accumulate fluid. Joint mobility is usually reduced.		010.2362
Arthritis, Juvenile Chronic
[description not available]		04.7361
Temporomandibular Disorders
[description not available]		0421
Arthritis, Juvenile
Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.		04.7361
Temporomandibular Joint Disorders
A variety of conditions affecting the anatomic and functional characteristics of the temporomandibular joint. Factors contributing to the complexity of temporomandibular diseases are its relation to dentition and mastication and the symptomatic effects in other areas which account for referred pain to the joint and the difficulties in applying traditional diagnostic procedures to temporomandibular joint pathology where tissue is rarely obtained and x-rays are often inadequate or nonspecific. Common diseases are developmental abnormalities, trauma, subluxation, luxation, arthritis, and neoplasia. (From Thoma's Oral Pathology, 6th ed, pp577-600)		0421
Aseptic Necrosis of Femur Head
[description not available]		04.01130
2019 Novel Coronavirus Disease
[description not available]		02.2510
Foot Diseases
Anatomical and functional disorders affecting the foot.		03.0950
Diseases, Occupational
[description not available]		02.940
Cumulative Trauma Disorders
Harmful and painful condition caused by overuse or overexertion of some part of the musculoskeletal system, often resulting from work-related physical activities. It is characterized by inflammation, pain, or dysfunction of the involved joints, bones, ligaments, and nerves.		02.4720
Foot Injuries
General or unspecified injuries involving the foot.		02.2510
Ganglion Cysts
Nodular tumor-like lesions or mucoid flesh, arising from tendon sheaths, LIGAMENTS, or JOINT CAPSULE, especially of the hands, wrists, or feet. They are not true cysts as they lack epithelial wall. They are distinguished from SYNOVIAL CYSTS by the lack of communication with a joint cavity or the SYNOVIAL MEMBRANE.		03.8621
Allergic Reaction
[description not available]		02.3820
Dermatitis
Any inflammation of the skin.		19.6930
Hypersensitivity
Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.		07.3820
Pemphigus Foliaceus
[description not available]		07.1510
Ovine Diseases
[description not available]		02.830
Pemphigus
Group of chronic blistering diseases characterized histologically by ACANTHOLYSIS and blister formation within the EPIDERMIS.		07.1510
Tendinitis
Inflammation of TENDONS. It is characterized by the degeneration of tendons accompanied by an inflammatory repair response, fibroblastic proliferation, and formation of granulation tissue. Tendinitis is not a clinical diagnosis and can be confirmed only by histopathological findings.		09.01139
Tendinopathy
Clinical syndrome describing overuse tendon injuries characterized by a combination of PAIN, diffuse or localized swelling, and impaired performance.		09.01139
Allodynia
[description not available]		02.1510
Nerve Pain
[description not available]		06100
Neuralgia
Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve.		113100
Joint Pain
[description not available]		012.812825
Osteoarthritis of Knee
[description not available]		015.274636
Arthralgia
Pain in the joint.		012.812825
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)		015.274636
Chronic Plantar Fasciitis
[description not available]		06.0333
Fasciitis, Plantar
Inflammation of the plantar fascia (APONEUROSIS) on the bottom of the foot causing heel pain. The etiology of plantar fasciitis remains controversial but is likely to involve a biomechanical imbalance. Though often presenting along with HEEL SPUR, they do not appear to be causally related.		06.0333
Flexor Tendon Entrapment
[description not available]		09.188
Anguilluliasis
[description not available]		02.730
Strongyloidiasis
Infection with nematodes of the genus STRONGYLOIDES. The presence of larvae may produce pneumonitis and the presence of adult worms in the intestine could lead to moderate to severe diarrhea.		02.730
Rheumatoid Arthritis
[description not available]		011.723112
Arthritis, Rheumatoid
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.		113.723112
Bone Spur
[description not available]		02.1710
Acute Post-operative Pain
[description not available]		09.591410
Pain, Postoperative
Pain during the period after surgery.		09.591410
Bone Fractures
[description not available]		02.4120
Fractures, Bone
Breaks in bones.		02.4120
Disease Exacerbation
[description not available]		02.4620
ACL Injuries
[description not available]		02.1710
Dysphagia
[description not available]		05.4222
Deglutition Disorders
Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS.		05.4222
Adhesive Capsulitis
[description not available]		011.452012
Bursitis
Inflammation or irritation of a SYNOVIAL BURSA, the fibrous sac that acts as a cushion between moving structures of bones, muscles, tendons or skin.		113.452012
Laryngeal Diseases
Pathological processes involving any part of the LARYNX which coordinates many functions such as voice production, breathing, swallowing, and coughing.		04.0931
HbS Disease
[description not available]		02.2110
Anemia, Sickle Cell
A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S.		02.2110
Amyotrophy, Thenar, Of Carpal Origin
[description not available]		012.723027
Carpal Tunnel Syndrome
Entrapment of the MEDIAN NERVE in the carpal tunnel, which is formed by the flexor retinaculum and the CARPAL BONES. This syndrome may be associated with repetitive occupational trauma (CUMULATIVE TRAUMA DISORDERS); wrist injuries; AMYLOID NEUROPATHIES; rheumatoid arthritis (see ARTHRITIS, RHEUMATOID); ACROMEGALY; PREGNANCY; and other conditions. Symptoms include burning pain and paresthesias involving the ventral surface of the hand and fingers which may radiate proximally. Impairment of sensation in the distribution of the median nerve and thenar muscle atrophy may occur. (Joynt, Clinical Neurology, 1995, Ch51, p45)		012.723027
Acute Symptom Flare
[description not available]		02.1710
Injuries, Knee
[description not available]		03.8621
Plica Syndrome
[description not available]		04.871
Knee Injuries
Injuries to the knee or the knee joint.		03.8621
Synovitis
Inflammation of the SYNOVIAL MEMBRANE.		09.871
Age-Related Osteoporosis
[description not available]		02.2110
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.		02.2110
Amaurosis
[description not available]		02.4520
Acute Retinal Necrosis
[description not available]		02.2110
Blindness
The inability to see or the loss or absence of perception of visual stimuli. This condition may be the result of EYE DISEASES; OPTIC NERVE DISEASES; OPTIC CHIASM diseases; or BRAIN DISEASES affecting the VISUAL PATHWAYS or OCCIPITAL LOBE.		02.4520
Degenerative Disc Disease
[description not available]		02.5420
Nerve Root Avulsion
[description not available]		010.43199
Low Back Ache
[description not available]		08.53208
Radiculopathy
Disease involving a spinal nerve root (see SPINAL NERVE ROOTS) which may result from compression related to INTERVERTEBRAL DISK DISPLACEMENT; SPINAL CORD INJURIES; SPINAL DISEASES; and other conditions. Clinical manifestations include radicular pain, weakness, and sensory loss referable to structures innervated by the involved nerve root.		010.43199
Spinal Stenosis
Narrowing of the spinal canal.		05.3472
Low Back Pain
Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.		110.53208
Intervertebral Disc Degeneration
Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.		02.5420
Pain, Chronic
[description not available]		05.3441
Eye Pain
A dull or sharp painful sensation associated with the outer or inner structures of the eyeball, having different causes.		03.1710
Chronic Pain
Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain.		17.3441
Diabetes Mellitus, Adult-Onset
[description not available]		08.786
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		08.786
Anterior Urethral Stricture
[description not available]		02.0810
Urethral Stricture
Narrowing of any part of the URETHRA. It is characterized by decreased urinary stream and often other obstructive voiding symptoms.		02.0810
Clinically Isolated CNS Demyelinating Syndrome
[description not available]		03.3220
Demyelinating Diseases
Diseases characterized by loss or dysfunction of myelin in the central or peripheral nervous system.		03.3220
Humeral Fractures
Fractures of the HUMERUS.		04.7240
Aspergillus Infection
[description not available]		02.0810
Fungal Meningitis
[description not available]		010.67170
Aspergillosis
Infections with fungi of the genus ASPERGILLUS.		02.0810
Infections, Soft Tissue
[description not available]		02.0810
Spinal Diseases
Diseases involving the SPINE.		07.48111
Soft Tissue Infections
Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)		02.0810
Calcification, Pathologic
[description not available]		07.173
Calcinosis
Pathologic deposition of calcium salts in tissues.		07.173
Shoulder Pain
Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin.		011.131915
Recrudescence
[description not available]		010.01238
Pachymeningitis
[description not available]		03.8340
Fungal Diseases
[description not available]		02.9540
Meningitis
Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)		03.8340
Mycoses
Diseases caused by FUNGI.		02.9540
Hemorrhage, Uterine
[description not available]		0310
Uterine Hemorrhage
Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.		0310
Apoplexy
[description not available]		05.0531
Stroke
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)		05.0531
Adrenal Gland Hypofunction
[description not available]		05.0752
Adrenal Insufficiency
Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.		05.0752
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		05.2462
Hospital-Acquired Condition
[description not available]		04.5790
Blood Poisoning
[description not available]		02.4120
Sepsis
Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.		02.4120
Elevated Cholesterol
[description not available]		02.0810
Hypercholesterolemia
A condition with abnormally high levels of CHOLESTEROL in the blood. It is defined as a cholesterol value exceeding the 95th percentile for the population.		02.0810
Coracohumeral Impingement
[description not available]		06.1943
Shoulder Impingement Syndrome
Compression of the ROTATOR CUFF tendons and subacromial bursa between the HUMERAL HEAD and the ACROMION of the SCAPULA. This condition is associated with subacromial BURSITIS, as well as rotator cuff (largely supraspinatus) and bicipital tendon INFLAMMATION.		18.1943
Chronic Illness
[description not available]		010.51912
Alarm Clock Headache
[description not available]		02.110
Abdominal Migraine
[description not available]		03.6130
Trigeminal Autonomic Cephalalgias
Primary headache disorders that show symptoms caused by the activation of the AUTONOMIC NERVOUS SYSTEM of the TRIGEMINAL NERVE. These autonomic features include redness and tearing of the EYE, nasal congestion or discharge, facial SWEATING and other symptoms. Most subgroups show unilateral cranial PAIN.		02.110
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		010.51912
Migraine Disorders
A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)		03.6130
Cataract, Membranous
[description not available]		03.2560
Prediabetes
[description not available]		02.110
Vision, Diminished
[description not available]		02.110
Cataract
Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed)		03.2560
Prediabetic State
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).		02.110
Uveitis
Inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (sclera and cornea, and the retina). (Dorland, 27th ed)		110.580
Health Care Associated Infection
[description not available]		02.110
Infections, Staphylococcal
[description not available]		02.4120
Cross Infection
Any infection which a patient contracts in a health-care institution.		02.110
Staphylococcal Infections
Infections with bacteria of the genus STAPHYLOCOCCUS.		02.4120
Disease Resistance
The capacity of an organism to defend itself against pathological processes or the agents of those processes. This most often involves innate immunity whereby the organism responds to pathogens in a generic way. The term disease resistance is used most frequently when referring to plants.		02.110
Caliciviridae Infections
Virus diseases caused by CALICIVIRIDAE. They include HEPATITIS E; VESICULAR EXANTHEMA OF SWINE; acute respiratory infections in felines, rabbit hemorrhagic disease, and some cases of gastroenteritis in humans.		02.110
Femoracetabular Impingement
A pathological mechanical process that can lead to hip failure. It is caused by abnormalities of the ACETABULUM and/or FEMUR combined with rigorous hip motion, leading to repetitive collisions that damage the soft tissue structures.		02.110
Polyarthritis
[description not available]		06.13123
Arthritis
Acute or chronic inflammation of JOINTS.		011.13123
Glenoid Labral Tears
[description not available]		02.5220
Athletic Injuries
Injuries incurred during participation in competitive or non-competitive sports.		02.4420
Injuries, Tendon
[description not available]		03.1350
Rotator Cuff Injuries
Injuries to the ROTATOR CUFF of the shoulder joint.		02.5220
Arthropathies
[description not available]		05.5661
Joint Diseases
Diseases involving the JOINTS.		05.5661
Anterior Cervical Pain
[description not available]		02.110
Neck Pain
Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to pain in the posterior or lateral regions of the neck.		02.110
B Virus Infection
[description not available]		04.3341
Infections, Respiratory
[description not available]		03.511
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		04.341
Respiratory Tract Infections
Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.		03.511
Ulnar Nerve Diseases
[description not available]		04.4422
Cubital Tunnel Syndrome
Compression of the ULNAR NERVE in the cubital tunnel, which is formed by the two heads of the flexor carpi ulnaris muscle, humeral-ulnar aponeurosis, and medial ligaments of the elbow. This condition may follow trauma or occur in association with processes which produce nerve enlargement or narrowing of the canal. Manifestations include elbow pain and PARESTHESIA radiating distally, weakness of ulnar innervated intrinsic hand muscles, and loss of sensation over the hypothenar region, fifth finger, and ulnar aspect of the ring finger. (Joynt, Clinical Neurology, 1995, Ch51, p43)		03.511
Congestive Ophthalmopathy
[description not available]		02.5220
Acute Liver Injury, Drug-Induced
[description not available]		02.5220
Graves Ophthalmopathy
An autoimmune disorder of the EYE, occurring in patients with Graves disease. Subtypes include congestive (inflammation of the orbital connective tissue), myopathic (swelling and dysfunction of the extraocular muscles), and mixed congestive-myopathic ophthalmopathy.		02.5220
Chemical and Drug Induced Liver Injury
A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.		02.5220
Rupture
Forcible or traumatic tear or break of an organ or other soft part of the body.		02.4220
Colicky Pain
[description not available]		03.3920
Abdominal Pain
Sensation of discomfort, distress, or agony in the abdominal region.		03.3920
Ankylosing Spondylarthritis
[description not available]		02.3720
Spondylitis, Ankylosing
A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.		02.3720
Arthritis, Spinal
[description not available]		03.5111
Trichostrongylosis
Infestation with nematode worms of the genus TRICHOSTRONGYLUS. Man and animals become infected by swallowing larvae, usually with contaminated food or drink, although the larvae may penetrate human skin.		02.1310
Weight Gain
Increase in BODY WEIGHT over existing weight.		02.1310
Adjuvant Arthritis
[description not available]		02.4120
External Ear Inflammation
[description not available]		02.1510
Necrosis
The death of cells in an organ or tissue due to disease, injury or failure of the blood supply.		02.4420
Otitis Externa
Inflammation of the OUTER EAR including the external EAR CANAL, cartilages of the auricle (EAR CARTILAGE), and the TYMPANIC MEMBRANE.		02.1510
Canine Diseases
[description not available]		04.4851
Bone Loss, Osteoclastic
[description not available]		02.4420
Candida Infection
[description not available]		03.3820
Cerebromeningitis
[description not available]		03.0610
Cerebral Cryptococcosis
[description not available]		03.0610
Aspergillosis, Nervous System Invasive
[description not available]		03.0610
Candidiasis
Infection with a fungus of the genus CANDIDA. It is usually a superficial infection of the moist areas of the body and is generally caused by CANDIDA ALBICANS. (Dorland, 27th ed)		03.3820
Meningitis, Cryptococcal
Meningeal inflammation produced by CRYPTOCOCCUS NEOFORMANS, an encapsulated yeast that tends to infect individuals with ACQUIRED IMMUNODEFICIENCY SYNDROME and other immunocompromised states. The organism enters the body through the respiratory tract, but symptomatic infections are usually limited to the lungs and nervous system. The organism may also produce parenchymal brain lesions (torulomas). Clinically, the course is subacute and may feature HEADACHE; NAUSEA; PHOTOPHOBIA; focal neurologic deficits; SEIZURES; cranial neuropathies; and HYDROCEPHALUS. (From Adams et al., Principles of Neurology, 6th ed, pp721-2)		03.0610
Neuroaspergillosis
Infections of the nervous system caused by fungi of the genus ASPERGILLUS, most commonly ASPERGILLUS FUMIGATUS. Aspergillus infections may occur in immunocompetent hosts, but are more prevalent in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES. The organism may spread to the nervous system from focal infections in the lung, mastoid region, sinuses, inner ear, bones, eyes, gastrointestinal tract, and heart. Sinus infections may be locally invasive and enter the intracranial compartment, producing MENINGITIS, FUNGAL; cranial neuropathies; and abscesses in the frontal lobes of the brain. (From Joynt, Clinical Neurology, 1998, Ch 27, pp62-3)		03.0610
Briquet Syndrome
[description not available]		02.1510
Somatoform Disorders
Disorders having the presence of physical symptoms that suggest a general medical condition but that are not fully explained by another medical condition, by the direct effects of a substance, or by another mental disorder. The MEDICALLY UNEXPLAINED SYMPTOMS must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. In contrast to FACTITIOUS DISORDERS and MALINGERING, the physical symptoms are not under voluntary control. (APA, DSM-V)		02.1510
Delirium of Mixed Origin
[description not available]		02.1510
Psychoses, Drug
[description not available]		02.1510
Delirium
A disorder characterized by CONFUSION; inattentiveness; disorientation; ILLUSIONS; HALLUCINATIONS; agitation; and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions. (From Adams et al., Principles of Neurology, 6th ed, pp411-2)		02.1510
Aging
The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time.		02.4420
Low Bone Density
[description not available]		03.150
Mandibular Diseases
Diseases involving the MANDIBLE.		02.0410
Bone Diseases, Metabolic
Diseases that affect the METABOLIC PROCESSES of BONE TISSUE.		03.150
Phlegmon
[description not available]		02.0410
Eperythrozoonosis
[description not available]		02.0410
Poultry Diseases
Diseases of birds which are raised as a source of meat or eggs for human consumption and are usually found in barnyards, hatcheries, etc. The concept is differentiated from BIRD DISEASES which is for diseases of birds not considered poultry and usually found in zoos, parks, and the wild.		02.0410
Cellulitis
An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions.		02.0410
Embolus
[description not available]		04.0831
Embolism
Blocking of a blood vessel by an embolus which can be a blood clot or other undissolved material in the blood stream.		04.0831
Polyuria
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).		02.0510
Postherpetic Neuralgia
[description not available]		010.3322
Shingles
[description not available]		06.4561
Acute Disease
Disease having a short and relatively severe course.		06.8193
Herpes Zoster
An acute infectious, usually self-limited, disease believed to represent activation of latent varicella-zoster virus (HERPESVIRUS 3, HUMAN) in those who have been rendered partially immune after a previous attack of CHICKENPOX. It involves the SENSORY GANGLIA and their areas of innervation and is characterized by severe neuralgic pain along the distribution of the affected nerve and crops of clustered vesicles over the area. (From Dorland, 27th ed)		06.4561
Neuralgia, Postherpetic
Pain in nerves, frequently involving facial SKIN, resulting from the activation the latent varicella-zoster virus (HERPESVIRUS 3, HUMAN). The two forms of the condition preceding the pain are HERPES ZOSTER OTICUS; and HERPES ZOSTER OPHTHALMICUS. Following the healing of the rashes and blisters, the pain sometimes persists.		05.3322
Central Nervous System Disease
[description not available]		02.9610
Central Nervous System Diseases
Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord.		02.9610
Epulides, Giant Cell
[description not available]		02.0510
Lip Diseases
Diseases involving the LIP.		02.0510
Granuloma Annulare
Benign granulomatous disease of unknown etiology characterized by a ring of localized or disseminated papules or nodules on the skin and palisading histiocytes surrounding necrobiotic tissue resulting from altered collagen structures.		02.0510
Granuloma, Giant Cell
A non-neoplastic inflammatory lesion, usually of the jaw or gingiva, containing large, multinucleated cells. It includes reparative giant cell granuloma. Peripheral giant cell granuloma refers to the gingiva (giant cell epulis); central refers to the jaw.		02.0510
Convulsions, Grand Mal
[description not available]		02.0510
Drug-Induced Stevens Johnson Syndrome
[description not available]		02.0510
Epilepsy, Tonic-Clonic
A generalized seizure disorder characterized by recurrent major motor seizures. The initial brief tonic phase is marked by trunk flexion followed by diffuse extension of the trunk and extremities. The clonic phase features rhythmic flexor contractions of the trunk and limbs, pupillary dilation, elevations of blood pressure and pulse, urinary incontinence, and tongue biting. This is followed by a profound state of depressed consciousness (post-ictal state) which gradually improves over minutes to hours. The disorder may be cryptogenic, familial, or symptomatic (caused by an identified disease process). (From Adams et al., Principles of Neurology, 6th ed, p329)		02.0510
Stevens-Johnson Syndrome
Rare cutaneous eruption characterized by extensive KERATINOCYTE apoptosis resulting in skin detachment with mucosal involvement. It is often provoked by the use of drugs (e.g., antibiotics and anticonvulsants) or associated with PNEUMONIA, MYCOPLASMA. It is considered a continuum of Toxic Epidermal Necrolysis.		02.0510
Injuries, Spinal Cord
[description not available]		02.9240
Spinal Cord Injuries
Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).		02.9240
Peripheral Nerve Diseases
[description not available]		03.3220
Peripheral Nervous System Diseases
Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves.		03.3220
Cirrhosis
[description not available]		02.420
Fibrosis
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.		02.420
Albers-Schoenberg Disease
[description not available]		02.9710
Osteopetrosis
Excessive formation of dense trabecular bone leading to pathological fractures; OSTEITIS; SPLENOMEGALY with infarct; ANEMIA; and extramedullary hemopoiesis (HEMATOPOIESIS, EXTRAMEDULLARY).		02.9710
Ochronosis
The yellowish discoloration of connective tissue due to deposition of HOMOGENTISIC ACID (a brown-black pigment). This is due to defects in the metabolism of PHENYLALANINE and TYROSINE. Ochronosis occurs in ALKAPTONURIA, but has also been associated with exposure to certain chemicals (e.g., PHENOL, trinitrophenol, BENZENE DERIVATIVES).		02.0510
Haemonchiasis
Infection with nematodes of the genus HAEMONCHUS, characterized by digestive abnormalities and anemia similar to that from hookworm infestation.		02.0610
Coxarthrosis
[description not available]		04.1431
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.		04.1431
Bone Marrow Diseases
Diseases involving the BONE MARROW.		02.0710
Anasarca
[description not available]		04.4751
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.		04.4751
Neuroretinitis
[description not available]		02.0610
Eye Infections, Viral
Infections of the eye caused by minute intracellular agents. These infections may lead to severe inflammation in various parts of the eye - conjunctiva, iris, eyelids, etc. Several viruses have been identified as the causative agents. Among these are Herpesvirus, Adenovirus, Poxvirus, and Myxovirus.		02.4220
Retinitis
Inflammation of the RETINA. It is rarely limited to the retina, but is commonly associated with diseases of the choroid (CHORIORETINITIS) and of the OPTIC DISK (neuroretinitis).		02.0610
Baker Cyst
[description not available]		03.6330
Infections, Taenia
[description not available]		02.0610
Taeniasis
Infection with tapeworms of the genus Taenia.		02.0610
Atrophy
Decrease in the size of a cell, tissue, organ, or multiple organs, associated with a variety of pathological conditions such as abnormal cellular changes, ischemia, malnutrition, or hormonal changes.		02.4420
Entrapment Neuropathies
[description not available]		04.6161
Bernhardt-Roth Syndrome
[description not available]		02.4620
Central Retinal Edema, Cystoid
[description not available]		04.3241
Cyclitis, Chronic
[description not available]		02.0710
Macular Edema
Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)		09.3241
Uveitis, Anterior
Inflammation of the anterior uvea comprising the iris, angle structures, and the ciliary body. Manifestations of this disorder include ciliary injection, exudation into the anterior chamber, iris changes, and adhesions between the iris and lens (posterior synechiae). Intraocular pressure may be increased or reduced.		02.420
Uveitis, Posterior
Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.		02.4320
Uveitis, Intermediate
Inflammation of the pars plana, ciliary body, and adjacent structures.		02.0710
Bone Tuberculosis
[description not available]		02.0710
Neuralgia, Sciatic
[description not available]		09.16136
Sciatica
A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA.		09.16136
Eosinophilic Granuloma
The most benign and common form of Langerhans-cell histiocytosis which involves localized nodular lesions predominantly of the bones but also of the gastric mucosa, small intestine, lungs, or skin, with infiltration by EOSINOPHILS.		02.6730
Bone Diseases
Diseases of BONES.		02.0710
Infection
[description not available]		03.8621
Infections, Prosthesis-Related
[description not available]		02.0710
Infections
Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases.		03.8621
Angiitis, Central Nervous System
[description not available]		02.0710
Back Ache
[description not available]		011.48228
Back Pain
Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.		011.48228
Bone Inflammation
[description not available]		02.0110
Symptom Cluster
[description not available]		06.4592
Syndrome
A characteristic symptom complex.		06.4592
Angioneurotic Edema
[description not available]		02.0110
Allergy, Drug
[description not available]		03.0850
Eosinophilia, Tropical
[description not available]		02.6830
Lassitude
[description not available]		02.0110
Endocarditis, Loeffler
[description not available]		02.0110
Angioedema
Swelling involving the deep DERMIS, subcutaneous, or submucosal tissues, representing localized EDEMA. Angioedema often occurs in the face, lips, tongue, and larynx.		02.0110
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		03.0850
Eosinophilia
Abnormal increase of EOSINOPHILS in the blood, tissues or organs.		02.6830
Fatigue
The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.		02.0110
Hypereosinophilic Syndrome
A heterogeneous group of disorders with the common feature of prolonged eosinophilia of unknown cause and associated organ system dysfunction, including the heart, central nervous system, kidneys, lungs, gastrointestinal tract, and skin. There is a massive increase in the number of EOSINOPHILS in the blood, mimicking leukemia, and extensive eosinophilic infiltration of the various organs.		02.0110
Pleural Effusion, Malignant
Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.		04.721
Inflammation, Endodontic
[description not available]		05.2722
Odontalgia
[description not available]		05.2722
Pulpitis
Inflammation of the DENTAL PULP, usually due to bacterial infection in dental caries, tooth fracture, or other conditions causing exposure of the pulp to bacterial invasion. Chemical irritants, thermal factors, hyperemic changes, and other factors may also cause pulpitis.		05.2722
Toothache
Pain in the adjacent areas of the teeth.		05.2722
Ulna Fractures
Fractures of the larger bone of the forearm.		02.0110
Cryptosporidium Infection
[description not available]		02.7230
Cryptosporidiosis
Intestinal infection with organisms of the genus CRYPTOSPORIDIUM. It occurs in both animals and humans. Symptoms include severe DIARRHEA.		02.7230
Cicatrization
The formation of fibrous tissue in the place of normal tissue during the process of WOUND HEALING. It includes scar tissue formation occurring in healing internal organs as well as in the skin after surface injuries.		04.0731
Cicatrix
The fibrous tissue that replaces normal tissue during the process of WOUND HEALING.		04.0731
Allergic Rhinitis
[description not available]		06.9310
Hay Fever
[description not available]		05.1841
Rhinitis, Allergic, Seasonal
Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.		05.1841
Rhinitis, Allergic
An inflammation of the NASAL MUCOSA triggered by ALLERGENS.		01.9310
Rheumatism
[description not available]		03.0450
Rheumatic Diseases
Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.		03.0450
Sclera Diseases
[description not available]		01.9310
Glaucoma
An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)		01.9310
Keratitis
Inflammation of the cornea.		02.6430
MS (Multiple Sclerosis)
[description not available]		05.54120
Multiple Sclerosis
An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)		05.54120
Middle Ear Effusion
[description not available]		01.9310
Otitis Media with Effusion
Inflammation of the middle ear with a clear pale yellow-colored transudate.		01.9310
Bovine Diseases
[description not available]		01.9310
Epidermal Cyst
Intradermal or subcutaneous saclike structure, the wall of which is stratified epithelium containing keratohyalin granules.		01.9310
Colitis Gravis
[description not available]		02.3520
Hemorrhagic Proctocolitis
[description not available]		01.9310
Colitis
Inflammation of the COLON section of the large intestine (INTESTINE, LARGE), usually with symptoms such as DIARRHEA (often with blood and mucus), ABDOMINAL PAIN, and FEVER.		01.9310
Colitis, Ulcerative
Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.		02.3520
Proctocolitis
Inflammation of the RECTUM and the distal portion of the COLON.		01.9310
Periarthritis
Inflammation of the tissues around a joint. (Dorland, 27th ed)		010.1560
Eczema, Atopic
[description not available]		01.9410
Dermatitis, Eczematous
[description not available]		01.9410
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.		01.9410
Eczema
A pruritic papulovesicular dermatitis occurring as a reaction to many endogenous and exogenous agents (Dorland, 27th ed).		06.9410
Nervous System Disorders
[description not available]		03.7940
Nervous System Diseases
Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.		03.7940
Libman-Sacks Disease
[description not available]		01.9410
Lupus Erythematosus, Systemic
A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.		01.9410
Eye Disorders
[description not available]		02.8840
Eye Diseases
Diseases affecting the eye.		02.8840
Diseases of Immune System
[description not available]		01.9410
Immune System Diseases
Disorders caused by abnormal or absent immunologic mechanisms, whether humoral, cell-mediated, or both.		01.9410
Licheniform Eruptions
[description not available]		02.0210
Colitis, Granulomatous
[description not available]		02.3920
Dermatitis Medicamentosa
[description not available]		02.6930
Palmoplantaris Pustulosis
[description not available]		02.0210
Cholecystoduodenal Fistula
[description not available]		02.0210
Hand Dermatosis
[description not available]		02.0210
Crohn Disease
A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.		02.3920
Hand Dermatoses
Skin diseases involving the HANDS.		02.0210
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		02.0210
Breast Diseases
Pathological processes of the BREAST.		02.0210
Epiretinal Membrane
A membrane on the vitreal surface of the retina resulting from the proliferation of one or more of three retinal elements: (1) fibrous astrocytes; (2) fibrocytes; and (3) RETINAL PIGMENT EPITHELIUM. Localized epiretinal membranes may occur at the posterior pole of the eye without clinical signs or may cause marked loss of vision as a result of covering, distorting, or detaching the FOVEA CENTRALIS. Epiretinal membranes may cause vascular leakage and secondary retinal edema. In younger individuals some membranes appear to be developmental in origin and occur in otherwise normal eyes. The majority occur in association with RETINAL HOLES, ocular concussions, retinal inflammation, or after ocular surgery. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p291)		02.0210
Cytomegaloviral Retinitis
[description not available]		02.0210
AIDS-Related Opportunistic Infections
Opportunistic infections found in patients who test positive for human immunodeficiency virus (HIV). The most common include PNEUMOCYSTIS PNEUMONIA, Kaposi's sarcoma, cryptosporidiosis, herpes simplex, toxoplasmosis, cryptococcosis, and infections with Mycobacterium avium complex, Microsporidium, and Cytomegalovirus.		02.0210
Cytomegalovirus Retinitis
Infection of the retina by cytomegalovirus characterized by retinal necrosis, hemorrhage, vessel sheathing, and retinal edema. Cytomegalovirus retinitis is a major opportunistic infection in AIDS patients and can cause blindness.		02.0210
Retinal Pigment Epithelial Detachment
[description not available]		02.940
Retinal Detachment
Separation of the inner layers of the retina (neural retina) from the pigment epithelium. Retinal detachment occurs more commonly in men than in women, in eyes with degenerative myopia, in aging and in aphakia. It may occur after an uncomplicated cataract extraction, but it is seen more often if vitreous humor has been lost during surgery. (Dorland, 27th ed; Newell, Ophthalmology: Principles and Concepts, 7th ed, p310-12).		02.940
Acquired Laryngeal Stenosis
[description not available]		02.3920
Tracheal Stenosis
A pathological narrowing of the TRACHEA.		02.0210
Gout
Metabolic disorder characterized by recurrent acute arthritis, hyperuricemia and deposition of sodium urate in and around the joints, sometimes with formation of URIC ACID calculi.		13.9310
Adrenal Gland Diseases
Pathological processes of the ADRENAL GLANDS.		01.9410
Common Migraine
[description not available]		02.0210
Cephalgia Syndromes
[description not available]		02.0210
Alopecia Cicatrisata
[description not available]		02.3920
Alopecia
Absence of hair from areas where it is normally present.		02.3920
Migraine without Aura
Recurrent unilateral pulsatile headaches, not preceded or accompanied by an aura, in attacks lasting 4-72 hours. It is characterized by PAIN of moderate to severe intensity; aggravated by physical activity; and associated with NAUSEA and / or PHOTOPHOBIA and PHONOPHOBIA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)		02.0210
Headache Disorders
Various conditions with the symptom of HEADACHE. Headache disorders are classified into major groups, such as PRIMARY HEADACHE DISORDERS (based on characteristics of their headache symptoms) and SECONDARY HEADACHE DISORDERS (based on their etiologies). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)		02.0210
Gait Disorders, Animal
[description not available]		02.9340
Facial Palsy
[description not available]		02.3920
Cadaver
A dead body, usually a human body.		02.0210
Cochlear Hearing Loss
[description not available]		02.0210
Hearing Loss, Sensorineural
Hearing loss resulting from damage to the COCHLEA and the sensorineural elements which lie internally beyond the oval and round windows. These elements include the AUDITORY NERVE and its connections in the BRAINSTEM.		02.0210
Aneurysmal Bone Cysts
[description not available]		02.0210
Mouth Ulcer
[description not available]		03.4111
Adamantiades-Behcet Disease
[description not available]		04.3822
Erythema Nodosum
An erythematous eruption commonly associated with drug reactions or infection and characterized by inflammatory nodules that are usually tender, multiple, and bilateral. These nodules are located predominantly on the shins with less common occurrence on the thighs and forearms. They undergo characteristic color changes ending in temporary bruise-like areas. This condition usually subsides in 3-6 weeks without scarring or atrophy.		03.4111
Female Genital Diseases
[description not available]		03.4111
Genital Diseases, Male
Pathological processes involving the male reproductive tract (GENITALIA, MALE).		03.4111
Behcet Syndrome
Rare chronic inflammatory disease involving the small blood vessels. It is of unknown etiology and characterized by mucocutaneous ulceration in the mouth and genital region and uveitis with hypopyon. The neuro-ocular form may cause blindness and death. SYNOVITIS; THROMBOPHLEBITIS; gastrointestinal ulcerations; RETINAL VASCULITIS; and OPTIC ATROPHY may occur as well.		04.3822
Genital Diseases, Female
Pathological processes involving the female reproductive tract (GENITALIA, FEMALE).		03.4111
Ulcer
A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.		03.821
Oral Ulcer
A loss of mucous substance of the mouth showing local excavation of the surface, resulting from the sloughing of inflammatory necrotic tissue. It is the result of a variety of causes, e.g., denture irritation, aphthous stomatitis (STOMATITIS, APHTHOUS); NOMA; necrotizing gingivitis (GINGIVITIS, NECROTIZING ULCERATIVE); TOOTHBRUSHING; and various irritants. (From Jablonski, Dictionary of Dentistry, 1992, p842)		03.4111
Clasp-Knife Spasticity
[description not available]		02.0210
Autonomic Hyperreflexia
[description not available]		02.0210
Muscle Spasticity
A form of muscle hypertonia associated with upper MOTOR NEURON DISEASE. Resistance to passive stretch of a spastic muscle results in minimal initial resistance (a free interval) followed by an incremental increase in muscle tone. Tone increases in proportion to the velocity of stretch. Spasticity is usually accompanied by HYPERREFLEXIA and variable degrees of MUSCLE WEAKNESS. (From Adams et al., Principles of Neurology, 6th ed, p54)		02.0210
Autonomic Dysreflexia
A syndrome associated with damage to the spinal cord above the mid thoracic level (see SPINAL CORD INJURIES) characterized by a marked increase in the sympathetic response to minor stimuli such as bladder or rectal distention. Manifestations include HYPERTENSION; TACHYCARDIA (or reflex bradycardia); FEVER; FLUSHING; and HYPERHIDROSIS. Extreme hypertension may be associated with a STROKE. (From Adams et al., Principles of Neurology, 6th ed, pp538 and 1232; J Spinal Cord Med 1997;20(3):355-60)		02.0210
Dermatoses
[description not available]		03.8221
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		03.8221
Diabetic Retinopathy
Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.		03.4111
Becker Muscular Dystrophy
[description not available]		02.0310
Cardiomyopathies, Primary
[description not available]		02.0310
Day Blindness
[description not available]		02.6830
Hemorrhage, Vitreous
[description not available]		02.0310
Neovascularization, Optic Disc
[description not available]		02.0310
Anemia
A reduction in the number of circulating ERYTHROCYTES or in the quantity of HEMOGLOBIN.		14.0310
Cardiomyopathies
A group of diseases in which the dominant feature is the involvement of the CARDIAC MUSCLE itself. Cardiomyopathies are classified according to their predominant pathophysiological features (DILATED CARDIOMYOPATHY; HYPERTROPHIC CARDIOMYOPATHY; RESTRICTIVE CARDIOMYOPATHY) or their etiological/pathological factors (CARDIOMYOPATHY, ALCOHOLIC; ENDOCARDIAL FIBROELASTOSIS).		02.0310
Vitreous Hemorrhage
Hemorrhage into the VITREOUS BODY.		02.0310
Retinal Neovascularization
Formation of new blood vessels originating from the retinal veins and extending along the inner (vitreal) surface of the retina.		02.0310
Muscular Dystrophy, Duchenne
An X-linked recessive muscle disease caused by an inability to synthesize DYSTROPHIN, which is involved with maintaining the integrity of the sarcolemma. Muscle fibers undergo a process that features degeneration and regeneration. Clinical manifestations include proximal weakness in the first few years of life, pseudohypertrophy, cardiomyopathy (see MYOCARDIAL DISEASES), and an increased incidence of impaired mentation. Becker muscular dystrophy is a closely related condition featuring a later onset of disease (usually adolescence) and a slowly progressive course. (Adams et al., Principles of Neurology, 6th ed, p1415)		02.0310
Neuroma
A tumor made up of nerve cells and nerve fibers. (Dorland, 27th ed)		02.0310
Diathesis
[description not available]		02.420
Cyst
[description not available]		02.3920
Polyps
Discrete abnormal tissue masses that protrude into the lumen of the DIGESTIVE TRACT or the RESPIRATORY TRACT. Polyps can be spheroidal, hemispheroidal, or irregular mound-shaped structures attached to the MUCOUS MEMBRANE of the lumen wall either by a stalk, pedunculus, or by a broad base.		02.0310
Besnier-Boeck Disease
[description not available]		02.3920
Granuloma of Larynx
[description not available]		02.0310
Sarcoidosis
An idiopathic systemic inflammatory granulomatous disorder comprised of epithelioid and multinucleated giant cells with little necrosis. It usually invades the lungs with fibrosis and may also involve lymph nodes, skin, liver, spleen, eyes, phalangeal bones, and parotid glands.		02.3920
Discitis
Inflammation of an INTERVERTEBRAL DISC or disk space which may lead to disk erosion. Until recently, discitis has been defined as a nonbacterial inflammation and has been attributed to aseptic processes (e.g., chemical reaction to an injected substance). However, recent studies provide evidence that infection may be the initial cause, but perhaps not the promoter, of most cases of discitis. Discitis has been diagnosed in patients following discography, myelography, lumbar puncture, paravertebral injection, and obstetrical epidural anesthesia. Discitis following chemonucleolysis (especially with chymopapain) is attributed to chemical reaction by some and to introduction of microorganisms by others.		02.4220
Air Embolism
[description not available]		02.0310
Benedict Syndrome
[description not available]		02.0310
Anterior Optic Neuritis
[description not available]		02.0310
Optic Neuritis
Inflammation of the optic nerve. Commonly associated conditions include autoimmune disorders such as MULTIPLE SCLEROSIS, infections, and granulomatous diseases. Clinical features include retro-orbital pain that is aggravated by eye movement, loss of color vision, and contrast sensitivity that may progress to severe visual loss, an afferent pupillary defect (Marcus-Gunn pupil), and in some instances optic disc hyperemia and swelling. Inflammation may occur in the portion of the nerve within the globe (neuropapillitis or anterior optic neuritis) or the portion behind the globe (retrobulbar neuritis or posterior optic neuritis).		14.0310
Arthritis, Post-Infectious
[description not available]		02.0310
Alpha Virus Infections
[description not available]		02.0310
Arthritis, Reactive
An aseptic, inflammatory arthritis developing secondary to a primary extra-articular infection, most typically of the GASTROINTESTINAL TRACT or UROGENITAL SYSTEM. The initiating trigger pathogens are usually SHIGELLA; SALMONELLA; YERSINIA; CAMPYLOBACTER; or CHLAMYDIA TRACHOMATIS. Reactive arthritis is strongly associated with HLA-B27 ANTIGEN.		02.0310
Complications of Diabetes Mellitus
[description not available]		02.0310
Emesis, Postoperative
[description not available]		03.4211
Bilateral Headache
[description not available]		06.0962
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		06.0962
Postoperative Nausea and Vomiting
Emesis and queasiness occurring after anesthesia.		03.4211
Age-Related Macular Degeneration
[description not available]		03.7921
Macular Degeneration
Degenerative changes in the RETINA usually of older adults which results in a loss of vision in the center of the visual field (the MACULA LUTEA) because of damage to the retina. It occurs in dry and wet forms.		03.7921
Dysesthesia
[description not available]		02.3920
Weight Reduction
[description not available]		02.0410
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		02.4220
Weight Loss
Decrease in existing BODY WEIGHT.		02.0410
Chronic Pancreatitis
[description not available]		02.9610
Cancer of Pancreas
[description not available]		02.9610
Pancreatic Neoplasms
Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).		02.9610
Pancreatitis, Chronic
INFLAMMATION of the PANCREAS that is characterized by recurring or persistent ABDOMINAL PAIN with or without STEATORRHEA or DIABETES MELLITUS. It is characterized by the irregular destruction of the pancreatic parenchyma which may be focal, segmental, or diffuse.		02.9610
Syndrome, VKH (Vogt Koyanagi Harada)
[description not available]		01.9310
Uveomeningoencephalitic Syndrome
A syndrome characterized by bilateral granulomatous UVEITIS with IRITIS and secondary GLAUCOMA, premature ALOPECIA, symmetrical VITILIGO, poliosis circumscripta (a strand of depigmented hair), HEARING DISORDERS, and meningeal signs (neck stiffness and headache). Examination of the cerebrospinal fluid reveals a pattern consistent with MENINGITIS, ASEPTIC. (Adams et al., Principles of Neurology, 6th ed, p748; Surv Ophthalmol 1995 Jan;39(4):265-292)		01.9310
Anaphylactic Reaction
[description not available]		05.241
Anaphylaxis
An acute hypersensitivity reaction due to exposure to a previously encountered ANTIGEN. The reaction may include rapidly progressing URTICARIA, respiratory distress, vascular collapse, systemic SHOCK, and death.		05.241
Cranial Nerve V Diseases
[description not available]		02.0410
Affective Psychosis, Bipolar
[description not available]		01.9610
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.		01.9610
Adrenal Gland Hyperfunction
[description not available]		01.9610
Adrenocortical Hyperfunction
Excess production of ADRENAL CORTEX HORMONES such as ALDOSTERONE; HYDROCORTISONE; DEHYDROEPIANDROSTERONE; and/or ANDROSTENEDIONE. Hyperadrenal syndromes include CUSHING SYNDROME; HYPERALDOSTERONISM; and VIRILISM.		01.9610
Femoral Fractures
Fractures of the femur.		02.6730
Femur Neck Fractures
[description not available]		01.9610
Femoral Neck Fractures
Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are HIP FRACTURES.		01.9610
Anemia, Hypoplastic
[description not available]		01.9610
Leucocythaemia
[description not available]		01.9610
Anemia, Aplastic
A form of anemia in which the bone marrow fails to produce adequate numbers of peripheral blood elements.		01.9610
Leukemia
A progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemias were originally termed acute or chronic based on life expectancy but now are classified according to cellular maturity. Acute leukemias consist of predominately immature cells; chronic leukemias are composed of more mature cells. (From The Merck Manual, 2006)		13.9610
Craniofacial Pain Syndromes
[description not available]		01.9610
Herpes Zoster, Ocular
[description not available]		02.3720
Herpes Zoster Ophthalmicus
Virus infection of the Gasserian ganglion and its nerve branches characterized by pain and vesicular eruptions with much swelling. Ocular involvement is usually heralded by a vesicle on the tip of the nose. This area is innervated by the nasociliary nerve.		02.3720
Myofascial Trigger Point Pain
[description not available]		05.2422
Myofascial Pain Syndromes
Muscular pain in numerous body regions that can be reproduced by pressure on TRIGGER POINTS, localized hardenings in skeletal muscle tissue. Pain is referred to a location distant from the trigger points. A prime example is the TEMPOROMANDIBULAR JOINT DYSFUNCTION SYNDROME.		05.2422
Pyrexia
[description not available]		01.9610
Fever
An abnormal elevation of body temperature, usually as a result of a pathologic process.		01.9610
Contact Dermatitis
[description not available]		01.9610
Dermatitis, Contact
A type of acute or chronic skin reaction in which sensitivity is manifested by reactivity to materials or substances coming in contact with the skin. It may involve allergic or non-allergic mechanisms.		01.9610
Spondylitis
Inflammation of the SPINE. This includes both arthritic and non-arthritic conditions.		01.9610
Bone Cancer
[description not available]		01.9610
Chondroblastoma
A usually benign tumor composed of cells which arise from chondroblasts or their precursors and which tend to differentiate into cartilage cells. It occurs primarily in the epiphyses of adolescents. It is relatively rare and represents less than 2% of all primary bone tumors. The peak incidence is in the second decade of life; it is about twice as common in males as in females. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1846)		01.9610
Fibromatosis
[description not available]		01.9610
Bone Neoplasms
Tumors or cancer located in bone tissue or specific BONES.		01.9610
Fibroma
A benign tumor of fibrous or fully developed connective tissue.		01.9610
Arachnoid Membrane Inflammation
[description not available]		04.7470
Fasting Hypoglycemia
HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast.		01.9610
Hypoglycemia
A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH.		01.9610
Fistula
Abnormal communication most commonly seen between two internal organs, or between an internal organ and the surface of the body.		02.8710
Abscess
Accumulation of purulent material in tissues, organs, or circumscribed spaces, usually associated with signs of infection.		02.8710
Rhinitis, Allergic, Nonseasonal
[description not available]		01.9610
Nasal Polyps
Focal accumulations of EDEMA fluid in the NASAL MUCOSA accompanied by HYPERPLASIA of the associated submucosal connective tissue. Polyps may be NEOPLASMS, foci of INFLAMMATION, degenerative lesions, or malformations.		01.9610
Rhinitis, Allergic, Perennial
Inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year. The causes are usually air-borne allergens, particularly dusts, feathers, molds, animal fur, etc.		01.9610
Kidney, Polycystic
[description not available]		03.5890
Polycystic Kidney Diseases
Hereditary diseases that are characterized by the progressive expansion of a large number of tightly packed CYSTS within the KIDNEYS. They include diseases with autosomal dominant and autosomal recessive inheritance.		03.5890
Experimental Lung Inflammation
Inflammation of any part, segment or lobe, of the lung parenchyma.		02.3720
Pneumonia
Infection of the lung often accompanied by inflammation.		02.3720
Endometrioma
An enlarged area of ENDOMETRIOSIS that resembles a tumor. It is usually found in the OVARY. When it is filled with old blood, it is known as a chocolate cyst.		02.3720
Endometriosis
A condition in which functional endometrial tissue is present outside the UTERUS. It is often confined to the PELVIS involving the OVARY, the ligaments, cul-de-sac, and the uterovesical peritoneum.		02.3720
Carcinoma 256, Walker
A transplantable carcinoma of the rat that originally appeared spontaneously in the mammary gland of a pregnant albino rat, and which now resembles a carcinoma in young transplants and a sarcoma in older transplants. (Stedman, 25th ed)		01.9610
Local Neoplasm Recurrence
[description not available]		02.3720
Besnoitiasis
[description not available]		02.3720
Swine Diseases
Diseases of domestic swine and of the wild boar of the genus Sus.		01.9610
Angioma
A vascular anomaly due to proliferation of blood or lymphatic vessels that forms a tumor-like mass. Vessels in the angioma may or may not be dilated.		02.3820
Orbital Neoplasms
Neoplasms of the bony orbit and contents except the eyeball.		01.9610
Hemangioma
A vascular anomaly due to proliferation of BLOOD VESSELS that forms a tumor-like mass. The common types involve CAPILLARIES and VEINS. It can occur anywhere in the body but is most frequently noticed in the SKIN and SUBCUTANEOUS TISSUE. (from Stedman, 27th ed, 2000)		02.3820
Allergic Alveolitis, Extrinsic
[description not available]		01.9610
Alveolitis, Extrinsic Allergic
A common interstitial lung disease caused by hypersensitivity reactions of PULMONARY ALVEOLI after inhalation of and sensitization to environmental antigens of microbial, animal, or chemical sources. The disease is characterized by lymphocytic alveolitis and granulomatous pneumonitis.		01.9610
Circulatory Collapse
[description not available]		01.9610
Shock
A pathological condition manifested by failure to perfuse or oxygenate vital organs.		01.9610
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		02.8940
Experimental Mammary Neoplasms
[description not available]		01.9510
Sterility, Female
[description not available]		02.3920
Endometrial Diseases
[description not available]		01.9810
Infertility, Female
Diminished or absent ability of a female to achieve conception.		02.3920
Uterine Diseases
Pathological processes involving any part of the UTERUS.		01.9810
Bleeding
[description not available]		01.9810
Angiitis
[description not available]		02.3920
Eosinophilia, Pulmonary
[description not available]		01.9810
Intestinal Diseases, Parasitic
Infections of the INTESTINES with PARASITES, commonly involving PARASITIC WORMS. Infections with roundworms (NEMATODE INFECTIONS) and tapeworms (CESTODE INFECTIONS) are also known as HELMINTHIASIS.		01.9810
Lung Diseases, Parasitic
Infections of the lungs with parasites, most commonly by parasitic worms (HELMINTHS).		01.9810
Hemorrhage
Bleeding or escape of blood from a vessel.		01.9810
Pulmonary Eosinophilia
A condition characterized by infiltration of the lung with EOSINOPHILS due to inflammation or other disease processes. Major eosinophilic lung diseases are the eosinophilic pneumonias caused by infections, allergens, or toxic agents.		01.9810
Vasculitis
Inflammation of any one of the blood vessels, including the ARTERIES; VEINS; and rest of the vasculature system in the body.		02.3920
Proliferative Vitreoretinopathy
[description not available]		01.9810
Vitreoretinopathy, Proliferative
Vitreoretinal membrane shrinkage or contraction secondary to the proliferation of primarily retinal pigment epithelial cells and glial cells, particularly fibrous astrocytes, followed by membrane formation. The formation of fibrillar collagen and cellular proliferation appear to be the basis for the contractile properties of the epiretinal and vitreous membranes.		01.9810
Proteinuria
The presence of proteins in the urine, an indicator of KIDNEY DISEASES.		02.3820
Disease, Pulmonary
[description not available]		02.3820
Lung Diseases
Pathological processes involving any part of the LUNG.		02.3820
Blood Pressure, Low
[description not available]		01.9810
Spondylisthesis
[description not available]		01.9810
Hypotension
Abnormally low BLOOD PRESSURE that can result in inadequate blood flow to the brain and other vital organs. Common symptom is DIZZINESS but greater negative impacts on the body occur when there is prolonged depravation of oxygen and nutrients.		01.9810
Protozoan Infections, Animal
Infections with unicellular organisms formerly members of the subkingdom Protozoa. The infections may be experimental or veterinary.		01.9810
Vaginal Diseases
Pathological processes of the VAGINA.		01.9810
Aortic Arteritis, Giant Cell
[description not available]		01.9810
Giant Cell Arteritis
A systemic autoimmune disorder that typically affects medium and large ARTERIES, usually leading to occlusive granulomatous vasculitis with transmural infiltrate containing multinucleated GIANT CELLS. The TEMPORAL ARTERY is commonly involved. This disorder appears primarily in people over the age of 50. Symptoms include FEVER; FATIGUE; HEADACHE; visual impairment; pain in the jaw and tongue; and aggravation of pain by cold temperatures. (From Adams et al., Principles of Neurology, 6th ed)		01.9810
Pars Planitis
Form of granulomatous uveitis occurring in the region of the pars plana. This disorder is a common condition with no detectable focal pathology. It causes fibrovascular proliferation at the inferior ora serrata.		01.9810
Hemorrhage, Retinal
[description not available]		01.9810
Kaposi Sarcoma
[description not available]		01.9810
Entrapment Syndrome, Ulnar Nerve
[description not available]		01.9810
Sarcoma, Kaposi
A multicentric, malignant neoplastic vascular proliferation characterized by the development of bluish-red cutaneous nodules, usually on the lower extremities, most often on the toes or feet, and slowly increasing in size and number and spreading to more proximal areas. The tumors have endothelium-lined channels and vascular spaces admixed with variably sized aggregates of spindle-shaped cells, and often remain confined to the skin and subcutaneous tissue, but widespread visceral involvement may occur. Kaposi's sarcoma occurs spontaneously in Jewish and Italian males in Europe and the United States. An aggressive variant in young children is endemic in some areas of Africa. A third form occurs in about 0.04% of kidney transplant patients. There is also a high incidence in AIDS patients. (From Dorland, 27th ed & Holland et al., Cancer Medicine, 3d ed, pp2105-7) HHV-8 is the suspected cause.		01.9810
Pain, Intractable
Persistent pain that is refractory to some or all forms of treatment.		02.3820
Contagious Pustular Dermatitis
[description not available]		01.9810
Delayed Hypersensitivity
[description not available]		02.3820
Sterility, Male
[description not available]		01.9910
Infertility, Male
The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility.		01.9910
Central Hypothyroidism
[description not available]		01.9910
Hypothyroidism
A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA. It may be primary or secondary due to other pituitary disease, or hypothalamic dysfunction.		01.9910
Injury, Ischemia-Reperfusion
[description not available]		01.9910
Ischemia
A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.		02.3820
Reperfusion Injury
Adverse functional, metabolic, or structural changes in tissues that result from the restoration of blood flow to the tissue (REPERFUSION) following ISCHEMIA.		01.9910
Algodystrophic Syndrome
[description not available]		01.9910
Reflex Sympathetic Dystrophy
A syndrome characterized by severe burning pain in an extremity accompanied by sudomotor, vasomotor, and trophic changes in bone without an associated specific nerve injury. This condition is most often precipitated by trauma to soft tissue or nerve complexes. The skin over the affected region is usually erythematous and demonstrates hypersensitivity to tactile stimuli and erythema. (Adams et al., Principles of Neurology, 6th ed, p1360; Pain 1995 Oct;63(1):127-33)		01.9910
ALS - Amyotrophic Lateral Sclerosis
[description not available]		01.9910
Adiadochokinesis
[description not available]		01.9910
Amyotrophic Lateral Sclerosis
A degenerative disorder affecting upper MOTOR NEURONS in the brain and lower motor neurons in the brain stem and SPINAL CORD. Disease onset is usually after the age of 50 and the process is usually fatal within 3 to 6 years. Clinical manifestations include progressive weakness, atrophy, FASCICULATION, hyperreflexia, DYSARTHRIA, dysphagia, and eventual paralysis of respiratory function. Pathologic features include the replacement of motor neurons with fibrous ASTROCYTES and atrophy of anterior SPINAL NERVE ROOTS and corticospinal tracts. (From Adams et al., Principles of Neurology, 6th ed, pp1089-94)		01.9910
Cerebellar Ataxia
Incoordination of voluntary movements that occur as a manifestation of CEREBELLAR DISEASES. Characteristic features include a tendency for limb movements to overshoot or undershoot a target (dysmetria), a tremor that occurs during attempted movements (intention TREMOR), impaired force and rhythm of diadochokinesis (rapidly alternating movements), and GAIT ATAXIA. (From Adams et al., Principles of Neurology, 6th ed, p90)		01.9910
Fasciitis, Necrotizing
A fulminating bacterial infection of the deep layers of the skin and FASCIA. It can be caused by many different organisms, with STREPTOCOCCUS PYOGENES being the most common.		01.9910
Group A Strep Infection
[description not available]		01.9910
Streptococcal Infections
Infections with bacteria of the genus STREPTOCOCCUS.		01.9910
Fasciitis
Inflammation of the fascia. There are three major types: 1, Eosinophilic fasciitis, an inflammatory reaction with eosinophilia, producing hard thickened skin with an orange-peel configuration suggestive of scleroderma and considered by some a variant of scleroderma; 2, Necrotizing fasciitis (FASCIITIS, NECROTIZING), a serious fulminating infection (usually by a beta hemolytic streptococcus) causing extensive necrosis of superficial fascia; 3, Nodular/Pseudosarcomatous /Proliferative fasciitis, characterized by a rapid growth of fibroblasts with mononuclear inflammatory cells and proliferating capillaries in soft tissue, often the forearm; it is not malignant but is sometimes mistaken for fibrosarcoma.		01.9910
Acquired Immune Deficiency Syndrome
[description not available]		01.9910
Acquired Immunodeficiency Syndrome
An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.		01.9910
Anus Diseases
Diseases involving the ANUS.		02.3820
Glaucoma, Suspect
[description not available]		02.420
Corneal Dystrophies
[description not available]		01.9910
Intraocular Pressure
The pressure of the fluids in the eye.		02.420
Ocular Hypertension
A condition in which the intraocular pressure is elevated above normal and which may lead to glaucoma.		02.420
Conjunctival Diseases
Diseases involving the CONJUNCTIVA.		01.9910
Brain Disorders
[description not available]		01.9910
Cerebrospinal Fluid Effusion, Subdural
[description not available]		01.9910
Brain Diseases
Pathologic conditions affecting the BRAIN, which is composed of the intracranial components of the CENTRAL NERVOUS SYSTEM. This includes (but is not limited to) the CEREBRAL CORTEX; intracranial white matter; BASAL GANGLIA; THALAMUS; HYPOTHALAMUS; BRAIN STEM; and CEREBELLUM.		01.9910
Bartonella henselae Infection
[description not available]		01.9910
Cat-Scratch Disease
A self-limiting bacterial infection of the regional lymph nodes caused by AFIPIA felis, a gram-negative bacterium recently identified by the Centers for Disease Control and Prevention and by BARTONELLA HENSELAE. It usually arises one or more weeks following a feline scratch, with raised inflammatory nodules at the site of the scratch being the primary symptom.		01.9910
Bacteremia
The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.		01.9910
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		03.3811
Conus Medullaris Syndrome
[description not available]		0210
Lipomatosis
A disorder characterized by the accumulation of encapsulated or unencapsulated tumor-like fatty tissue resembling LIPOMA.		0210
Embolism, Fat
Blocking of a blood vessel by fat deposits in the circulation. It is often seen after fractures of large bones or after administration of CORTICOSTEROIDS.		0210
Lymphocytopenia
[description not available]		0210
P carinii Pneumonia
[description not available]		0210
Lymphopenia
Reduction in the number of lymphocytes.		0210
Pneumonia, Pneumocystis
A pulmonary disease in humans occurring in immunodeficient or malnourished patients or infants, characterized by DYSPNEA, tachypnea, and HYPOXEMIA. Pneumocystis pneumonia is a frequently seen opportunistic infection in AIDS. It is caused by the fungus PNEUMOCYSTIS JIROVECII. The disease is also found in other MAMMALS where it is caused by related species of Pneumocystis.		0210
Mast Cell Activation Disease
[description not available]		0210
Mucinoses
Mucoid states characterized by the elevated deposition and accumulation of mucin (mucopolysaccharides) in dermal tissue. The fibroblasts are responsible for the production of acid mucopolysaccharides (GLYCOSAMINOGLYCANS) in the ground substance of the connective tissue system. When fibroblasts produce abnormally large quantities of mucopolysaccharides as hyaluronic acid, chondroitin sulfate, or heparin, they accumulate in large amounts in the dermis.		0210
Mastocytosis
A rare neoplastic disorder characterized by a clonal proliferation of MAST CELLS, associated with KIT-D816 mutations, and accompanied by aberrant mast cell activation. The abnormal increase of MAST CELLS may occur in only the skin (MASTOCYTOSIS, CUTANEOUS), in extracutaneous tissues involving multiple organs (MASTOCYTOSIS, SYSTEMIC), or in solid tumors (MASTOCYTOMA).		0210
Nasal Diseases
[description not available]		02.3820
Thromboembolism
Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.		0210
AIDS, Feline
[description not available]		0210
Viremia
The presence of viruses in the blood.		0210
Arthritides, Bacterial
[description not available]		0210
Forestier-Certonciny Syndrome
[description not available]		03.3911
Polymyalgia Rheumatica
A syndrome in the elderly characterized by proximal joint and muscle pain, high erythrocyte sedimentation rate, and a self-limiting course. Pain is usually accompanied by evidence of an inflammatory reaction. Women are affected twice as commonly as men and Caucasians more frequently than other groups. The condition is frequently associated with GIANT CELL ARTERITIS and some theories pose the possibility that the two diseases arise from a single etiology or even that they are the same entity.		03.3911
Deaf Mutism
[description not available]		0210
Deafness
A general term for the complete loss of the ability to hear from both ears.		0210
Osteophytosis, Spinal
[description not available]		0210
Cushing's Syndrome
[description not available]		0210
Stunted Growth
[description not available]		0210
Hair Diseases
Diseases affecting the orderly growth and persistence of hair.		0210
Acanthosis Nigricans
A circumscribed melanosis consisting of a brown-pigmented, velvety verrucosity or fine papillomatosis appearing in the axillae and other body folds. It occurs in association with endocrine disorders, underlying malignancy, administration of certain drugs, or as in inherited disorder.		0210
Cyclitis, Heterochromic
[description not available]		0210
Cushing Syndrome
A condition caused by prolonged exposure to excess levels of cortisol (HYDROCORTISONE) or other GLUCOCORTICOIDS from endogenous or exogenous sources. It is characterized by upper body OBESITY; OSTEOPOROSIS; HYPERTENSION; DIABETES MELLITUS; HIRSUTISM; AMENORRHEA; and excess body fluid. Endogenous Cushing syndrome or spontaneous hypercortisolism is divided into two groups, those due to an excess of ADRENOCORTICOTROPIN and those that are ACTH-independent.		0210
Growth Disorders
Deviations from the average values for a specific age and sex in any or all of the following: height, weight, skeletal proportions, osseous development, or maturation of features. Included here are both acceleration and retardation of growth.		0210
Iridocyclitis
Acute or chronic inflammation of the iris and ciliary body characterized by exudates into the anterior chamber, discoloration of the iris, and constricted, sluggish pupil. Symptoms include radiating pain, photophobia, lacrimation, and interference with vision.		0210
Allergic Contact Dermatitis
[description not available]		0210
Dermatitis, Allergic Contact
A contact dermatitis due to allergic sensitization to various substances. These substances subsequently produce inflammatory reactions in the skin of those who have acquired hypersensitivity to them as a result of prior exposure.		0210
Osteolysis
Dissolution of bone that particularly involves the removal or loss of calcium.		0210
Embryopathies
[description not available]		0210
Thrombopenia
[description not available]		0210
Thrombocytopenia
A subnormal level of BLOOD PLATELETS.		0210
Keloid
A sharply elevated, irregularly shaped, progressively enlarging scar resulting from formation of excessive amounts of collagen in the dermis during connective tissue repair. It is differentiated from a hypertrophic scar (CICATRIX, HYPERTROPHIC) in that the former does not spread to surrounding tissues.		0210
Hallux Rigidus
A condition caused by degenerative arthritis (see OSTEOARTHRITIS) of the METATARSOPHALANGEAL JOINT of the great toe and characterized by pain and limited dorsiflexion, but relatively unrestricted plantar flexion.		0210
Diplopia
A visual symptom in which a single object is perceived by the visual cortex as two objects rather than one. Disorders associated with this condition include REFRACTIVE ERRORS; STRABISMUS; OCULOMOTOR NERVE DISEASES; TROCHLEAR NERVE DISEASES; ABDUCENS NERVE DISEASES; and diseases of the BRAIN STEM and OCCIPITAL LOBE.		04.6921
Exophthalmos
Abnormal protrusion of both eyes; may be caused by endocrine gland malfunction, malignancy, injury, or paralysis of the extrinsic muscles of the eye.		04.3111
Basedow Disease
[description not available]		05.5332
Graves Disease
A common form of hyperthyroidism with a diffuse hyperplastic GOITER. It is an autoimmune disorder that produces antibodies against the THYROID STIMULATING HORMONE RECEPTOR. These autoantibodies activate the TSH receptor, thereby stimulating the THYROID GLAND and hypersecretion of THYROID HORMONES. These autoantibodies can also affect the eyes (GRAVES OPHTHALMOPATHY) and the skin (Graves dermopathy).		05.5332
Herpes Simplex Virus Infection
[description not available]		0210
Herpes Simplex
A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.)		0210
Mucositis, Oral
[description not available]		0210
Stomatitis
INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.		0210
Injuries, Needlestick
[description not available]		02.0110
Eye Injuries, Penetrating
Deeply perforating or puncturing type intraocular injuries.		02.0110
Retinal Degeneration
A retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)		02.0110
Smoking Cessation
Discontinuing the habit of SMOKING.		02.0110
Branch Retinal Artery Occlusion
[description not available]		02.0110
Choroid Diseases
Disorders of the choroid including hereditary choroidal diseases, neoplasms, and other abnormalities of the vascular layer of the uvea.		02.0110
Cancer of Nose
[description not available]		02.0110
Retinal Artery Occlusion
Sudden ISCHEMIA in the RETINA due to blocked blood flow through the CENTRAL RETINAL ARTERY or its branches leading to sudden complete or partial loss of vision, respectively, in the eye.		02.0110
Dupuytren's Contracture
[description not available]		02.0110
Dupuytren Contracture
A fibromatosis of the palmar fascia characterized by thickening and contracture of the fibrous bands on the palmar surfaces of the hand and fingers. It arises most commonly in men between the ages of 30 and 50.		02.0110
Angiogenesis, Pathologic
[description not available]		01.9810
Dupre Syndrome
[description not available]		02.3820
Pleural Effusion
Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.		01.9810
Impotence
[description not available]		01.9710
Erectile Dysfunction
The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.		01.9710
Craniofacial Pain
[description not available]		01.9710
Facial Pain
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.		06.9710
Bright Disease
A historical classification which is no longer used. It described acute glomerulonephritis, acute nephritic syndrome, or acute nephritis. Named for Richard Bright.		01.9710
Glomerulonephritis
Inflammation of the renal glomeruli (KIDNEY GLOMERULUS) that can be classified by the type of glomerular injuries including antibody deposition, complement activation, cellular proliferation, and glomerulosclerosis. These structural and functional abnormalities usually lead to HEMATURIA; PROTEINURIA; HYPERTENSION; and RENAL INSUFFICIENCY.		01.9710
Rupture, Spontaneous
Tear or break of an organ, vessel or other soft part of the body, occurring in the absence of external force.		01.9710
Carcinoma, Anaplastic
[description not available]		01.9710
Neoplasm Metastasis, Unknown Primary
[description not available]		01.9710
Carcinoma
A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm and not a synonym for cancer.		01.9710
Optic Atrophy
Atrophy of the optic disk which may be congenital or acquired. This condition indicates a deficiency in the number of nerve fibers which arise in the RETINA and converge to form the OPTIC DISK; OPTIC NERVE; OPTIC CHIASM; and optic tracts. GLAUCOMA; ISCHEMIA; inflammation, a chronic elevation of intracranial pressure, toxins, optic nerve compression, and inherited conditions (see OPTIC ATROPHIES, HEREDITARY) are relatively common causes of this condition.		01.9710
Synovial Cyst
Non-neoplastic tumor-like lesions at joints, developed from the SYNOVIAL MEMBRANE of a joint through the JOINT CAPSULE into the periarticular tissues. They are filled with SYNOVIAL FLUID with a smooth and translucent appearance. A synovial cyst can develop from any joint, but most commonly at the back of the knee, where it is known as POPLITEAL CYST.		02.3720
Arterial Diseases, Carotid
[description not available]		01.9710
Carotid Artery Diseases
Pathological conditions involving the CAROTID ARTERIES, including the common, internal, and external carotid arteries. ATHEROSCLEROSIS and TRAUMA are relatively frequent causes of carotid artery pathology.		01.9710
Infections, Paramyxoviridae
[description not available]		01.9710
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.		01.9710
Inferior Dislocation
[description not available]		01.9710
Scotoma
A localized defect in the visual field bordered by an area of normal vision. This occurs with a variety of EYE DISEASES (e.g., RETINAL DISEASES and GLAUCOMA); OPTIC NERVE DISEASES, and other conditions.		01.9710
Adhesions, Tissue
[description not available]		01.9610
Adnexitis
Inflammation of the uterine appendages (ADNEXA UTERI) including infection of the FALLOPIAN TUBES (SALPINGITIS), the ovaries (OOPHORITIS), or the supporting ligaments (PARAMETRITIS).		01.9610
Pelvic Inflammatory Disease
A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.		01.9610
Injuries
Used with anatomic headings, animals, and sports for wounds and injuries. Excludes cell damage, for which pathology is used.		01.9710
Wounds and Injuries
Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity.		01.9710
Furrow Keratitis
[description not available]		01.9610
Emesis
[description not available]		03.3511
Nausea
An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.		08.3511
Vomiting
The forcible expulsion of the contents of the STOMACH through the MOUTH.		03.3511
Ectopic Ossification
[description not available]		01.9710
Eyelid Diseases
Diseases involving the EYELIDS.		03.3511
Blepharitis
Inflammation of the eyelids.		03.3511
Abscess, Amebic
[description not available]		01.9710
Complications, Pregnancy
[description not available]		01.9710
Amebiasis
Infection with any of various amebae. It is an asymptomatic carrier state in most individuals, but diseases ranging from chronic, mild diarrhea to fulminant dysentery may occur.		01.9710
Ptosis, Eyelid
[description not available]		01.9710
Anti-MuSK Myasthenia Gravis
[description not available]		01.9710
Blepharoptosis
Drooping of the upper lid due to deficient development or paralysis of the levator palpebrae muscle.		01.9710
Myasthenia Gravis
A disorder of neuromuscular transmission characterized by fatigable weakness of cranial and skeletal muscles with elevated titers of ACETYLCHOLINE RECEPTORS or muscle-specific receptor tyrosine kinase (MuSK) autoantibodies. Clinical manifestations may include ocular muscle weakness (fluctuating, asymmetric, external ophthalmoplegia; diplopia; ptosis; and weakness of eye closure) and extraocular fatigable weakness of facial, bulbar, respiratory, and proximal limb muscles. The disease may remain limited to the ocular muscles (ocular myasthenia). THYMOMA is commonly associated with this condition.		01.9710
Adiposalgia
[description not available]		01.9710
Chronic Primary Open Angle Glaucoma
[description not available]		01.9710
Glaucoma, Open-Angle
Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.		01.9710
Leukocytosis
A transient increase in the number of leukocytes in a body fluid.		01.9610
Nerve Degeneration
Loss of functional activity and trophic degeneration of nerve axons and their terminal arborizations following the destruction of their cells of origin or interruption of their continuity with these cells. The pathology is characteristic of neurodegenerative diseases. Often the process of nerve degeneration is studied in research on neuroanatomical localization and correlation of the neurophysiology of neural pathways.		01.9610
Respiratory Tract Diseases
Diseases involving the RESPIRATORY SYSTEM.		01.9610
Idiopathic Inflammatory Myopathies
[description not available]		01.9610
Muscle Contraction
A process leading to shortening and/or development of tension in muscle tissue. Muscle contraction occurs by a sliding filament mechanism whereby actin filaments slide inward among the myosin filaments.		01.9610
Myositis
Inflammation of a muscle or muscle tissue.		01.9610
Cancer of Lung
[description not available]		01.9610
Malignant Melanoma
[description not available]		01.9610
Actinic Reticuloid Syndrome
[description not available]		01.9610
Lung Neoplasms
Tumors or cancer of the LUNG.		01.9610
Melanoma
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)		01.9610
Pink Eye
[description not available]		01.9610
Conjunctivitis
INFLAMMATION of the CONJUNCTIVA.		01.9610
Stye
[description not available]		01.9610
Hordeolum
Purulent infection of one of the sebaceous glands of Zeis along the eyelid margin (external) or of the meibomian gland on the conjunctival side of the eyelid (internal).		01.9610
chemdatabank.com